Locking Plates PCA8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188100765), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K060041); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 19, 2018Fracture; Fracture

  TRIMED RECEIVED THE FOLLOWING REPORT OF (B)(6) 2018 FROM TRIMED SALES MEMBER LOCATED IN THE UNITED STATES, REGARDING THE LOCKING PLATE, CURVED A, 8-HOLE: DURING A POST-OPERATIVE X-RAY SCAN, IT WAS DISCOVERED THAT LOCKING, CURVED A, 8-HOLE (PCA8) HAD BROKEN AND WOULD NEED TO BE EXPLANTED ON (B)(6) 2018. TRIMED HAS CONTACTED THE SALES MEMBER MORE THAN THREE TIMES TO GETHER FURTHER INFORMATION REGARDING THIS COMPLAINT AND THE ATTEMPTS HAVE BEEN UNSUCCESSFUL. THIS IS THE FIRST TIME THIS TYPE OF MALFUNCTION HAS BEEN REPORTED TO TRIMED FOR THIS PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7987517 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060041. One submission often covers many models, so check the product and lot details in each record.

• Z-1214-2019 · Aug 24, 2018 · Terminated
  TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle
• Z-0366-2020 · Aug 15, 2018 · Terminated
  TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset
• Z-2849-2016 · Aug 29, 2016 · Terminated
  TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of sur