Peri-Loc 73827085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556071922), received between Mar 19, 2021 and Mar 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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.

• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A 4.5MM L-D FEM LK PL13H R 286MM PLATE HAD BEEN IMPLANTED, THE FRACTURE WAS RADIOLOGICALLY SEEN AS DISPLACED AND NOT CONSOLIDATED. THERE WAS ALSO EVIDENCE OF SCREW BREAKAGE AND LOOSENING AT THE DISTAL PART. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ADVERSE EVENT. UPON PLATE EXTRACTION, IT WAS EVIDENT THAT ALL LOCKING SCREWS IN THE DISTAL AREA WERE LOOSE: THEY WERE NOT LOCKED IN THE PLATE. ALL HARDWARE WAS SUCCESSFULLY REMOVED AND REPLACED WITH AN INTERTAN NAIL. THE PATIENT IS STABLE AND IN GOOD HEALTH. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 11528992 ↗