TRIGEN 71640540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556339244), received between Sep 22, 2021 and Nov 9, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT AN INTERNAL FIXATION SURGERY DUE TO A FEMUR FRACTURE ON THE RIGHT LOWER EXTREMITY ON (B)(6) 2023. PATIENT RECOVERY WAS DOING WELL, AND HE WAS PARTIALLY BEARING WEIGHT ON THE RIGHT LOWER EXTREMITY WITH CRUTCHES. ON (B)(6) 2023, THE PATIENT DID NOT WEAR THE COMPRESSION STOCKING AT SCHOOL AND DURING THE EVENING, THE PATIENT GOT UP AND FELT THE RIGHT KNEE AND RIGHT DISTAL THIGH WAS STARTING TO FEEL STIFF AND TIGHTER AND WHEN TRYING TO MOVE THE RIGHT KNEE JOINT, THEY NOTED THAT IT SOUNDED LIKE THERE WAS SOME CLICKING. SINCE 8 PM OF THAT DAY, THE PATIENT HAS NOT BEEN ABLE TO BEAR WEIGHT ON THE RIGHT LOWER EXTREMITY. THE PATIENT DENIED ANY NUMBNESS, TINGLING, FEVER, NAUSEA, AND VOMITING. PATIENT HAS NOT NOTICED ANY REDNESS OVER THE AREA OF THE RIGHT KNEE OR THIGH BUT HAS STATED THAT THEY HAVE NOT BEEN ABLE TO BEND THE KNEE FULLY AS THEY WERE ABLE TO EARLIER IN THE DAY. IMAGING WAS PERFORMED TO THE PATIENT AND DEMONSTRATED IMPLANT FAILURE ABOUT THE FRACTURE SITE, THE DISTAL PORTION OF THE INTRAMEDULLARY NAIL WAS FRACTURED. THIS COMPLICATION WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2023. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 18104838 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 11 MONTHS AFTER A PROCEDURE HAD BEEN PERFORMED WITH TRIGEN TRAPTAN 9MM X 40CM RIGHT TO TREAT A SIMPLE LONG BONE FRACTURE IN THE MIDSHAFT REGION OF THE FEMUR, THE PATIENT SUFFERED A PERIPROSTHETIC FRACTURE THAT LED TO AN ORIF - REVISION SURGERY BEEN PERFORMED IN ANOTHER CENTER. THE PATIENT'S OUTCOME, AFTER 3 MONTHS OF THE REVISION SURGERY, WAS REFERRED TO A CORRECT FRACTURE UNION. 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.

  Patient problems: Limb Fracture

  MAUDE report 12512748 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 10 MONTHS AFTER A PROCEDURE HAD BEEN PERFORMED WITH TRIGEN TRAPTAN 9 MM X 40 CM RIGHT TO TREAT A SIMPLE LONG BONE FRACTURE IN THE MIDSHAFT REGION OF THE FEMUR, THE PATIENT'S OUTCOME WAS NOT SUCCESSFUL, AS THE FRACTURE WAS NOT COMPLETELY REDUCED. A REVISION SURGERY WAS PERFORMED TO TREAT THIS ADVERSE EVENT. THE TRIGEN TRAPTAN 9 MM X 40 CM RIGHT WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED NAIL, WITH THE SUBSEQUENT UNION OF THE FRACTURE. IT IS UNKNOWN HOW MUCH TIME TOOK TO ACHIEVE THE REPORTED FINAL OUTCOME. 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.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12512581 ↗

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