Peri-Loc 71867056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010641649), received between Aug 19, 2020 and Aug 19, 2020 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K083032, K210837); 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.

• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, AFTER DRILLING AND INSERTING SEVERAL SCREWS INTO THE SCREW HOLES ON THE PLATE, ONE SCREW DID NOT SEAT PROPERLY. THE PERI-LOC 4.5 MM T25 TITANIUM LOCKING SCREW 56 MM SELF-TAPPING SEEMED TO KEEP PROCEEDING, ALTHOUGH THERE WAS SLIGHT RESISTANCE DURING INSERTING, SO THE SURGEON FELT THE SCREW MIGHT NOT STOP AND ITS SCREW HEAD SEEMED TO ALMOST REACH THE BONE WHEN CONFIRMING IMAGE. THE PERI-LOC 4.5 MM T25 TITANIUM LOCKING SCREW 56 MM SELF-TAPPING WAS REMOVED AND COMPARED ITS SCREW HEAD WITH OTHER'S SCREW HEAD, BUT SIGNIFICANT DIFFERENCE WAS NOT FOUND. THE PROCEDURE WAS COMPLETED AFTER INSERTING OTHER SCREWS INTO OTHER SCREW HOLES ON THE PLATE. THE PERI-LOC 4.5 MM TITANIUM LAT DIST FEMUR PLATE 6H L 155 MM WAS IMPLANTED AND LEFT IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SURGICAL DELAY OF 10 MINUTES. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10426649 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083032, K210837. One submission often covers many models, so check the product and lot details in each record.

• Z-0373-2016 · Oct 20, 2015 · Terminated
  Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
• Z-0372-2016 · Oct 20, 2015 · Terminated
  Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate