TRIGEN 71649536Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556338599), received between Dec 20, 2022 and Dec 20, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K092748, K243364); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A MECHANICAL COMPLICATION OF THE NAIL AFTER HAVING A FRACTURE FIXATION SURGERY OF THE LEFT FEMUR USING THE TRIGEN META-TAN SYSTEM. THERE IS INSTABILITY OF THE DISTAL SEGMENT OF THE FEMUR WITH LATERAL DISPLACEMENT RELATIVE TO NAIL AND ITS PREVIOUS POSITION. THE DISTAL SEGMENT APPEARS UNSTABLE AND MOBILE, CAUSING SIGNIFICANT PAIN AND DISCOMFORT. THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS THE ISSUE. IT IS UNKNOWN IF THE PATIENT ACHIEVED UNION. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT. WE DO NOT HAVE THE OPPORTUNITY TO IDENTIFY INDIVIDUAL HCPS AND REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Discomfort; Failure of Implant; Joint Laxity; Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Tissue Injury

  MAUDE report 16015672 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092748, K243364. One submission often covers many models, so check the product and lot details in each record.

• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690