LCP 02.112.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982032713), received between Jul 28, 2020 and Aug 11, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WILL UNDERGO REVISION SURGERY DUE TO A BROKEN PLATE. THE DOCTOR REPORTS THAT THE CLAVICLE PLATE PLACED ON THE PATIENT HAS BROKEN DUE TO FATIGUE, FOR WHICH THEY ARE GOING TO REMOVE THE IMPLANT AND PLACE ANOTHER ONE. PATIENT ALSO EXPERIENCED PAIN. THIS REPORT IS FOR A 3.5MM LOCKING COMPRESSION PLATE (LCP) SUP ANT CLAVICLE PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12306816 ↗
• MalfunctionJul 28, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS (B)(4) SITE ON AN UNKNOWN DATE, THE LOCKING COMPRESSION PLATE (LCP) SUPERIOR ANTERIOR CLAVICLE PLATE WAS OBSERVED DAMAGED WITH A SCRATCHED PLATE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335654 ↗