PRODUCT CODE DZE
Implant, Endosseous, Root-Form
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Injury reports · review source evidence. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
196,123Prior 90 days: 181,826Injury reports
195,874Source-classified event typeDeath reports
1Reported relationship is unverifiedReporting change
7.9%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 232. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
Tuff Implant
Read FDA report 50515267 ↗Received 2026-08-31 · Injury
Patient problems: Failure of Implant; Implant Pain
Device problems: Loosening of Implant Not Related to Bone-Ingrowth
Tuff UniCon Implant
Read FDA report 50515269 ↗Received 2026-08-31 · Injury
Patient problems: Osteolysis
Device problems: Loss of Osseointegration
Tuff TT Implant
Read FDA report 50515272 ↗Received 2026-08-31 · Injury
Patient problems: Failure of Implant; Unspecified Infection; Osteolysis; Implant Pain
Device problems: Loss of Osseointegration
Tuff UniCon Implant
Read FDA report 50515275 ↗Received 2026-08-31 · Injury
Patient problems: Failure of Implant; Unspecified Infection; Osteolysis
Device problems: Loss of Osseointegration
Tuff Unicon Implant
Read FDA report 50515280 ↗Received 2026-08-31 · Injury
Patient problems: Implant Pain
Device problems: Loosening of Implant Not Related to Bone-Ingrowth
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.