LCP 245.121Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982169686), received between Jan 19, 2018 and Nov 5, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000684); 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 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE WITH ANATOMIC REDUCTION FOR THE 3 CORTEX SCREW DUE TO MALALIGNMENT OF DISTAL ULNA FRACTURE. THE PROXIMAL SCREWS WERE RETAINED. DISTAL SCREW REMOVED AS PART OF A DISTAL FRACTUR RE-ALIGNMENT. ONCE REDUCTION WAS RESTORED, NEW DISTAL SCREWS WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS REPORT IS FOR 1 3.5MM LCP RECONSTRUCTION PLATE 12 HOLES/168MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10793520 ↗
• InjuryJul 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A POSTEROLATERAL DISTAL HUMERUS PLATE AND A 3.5 LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE DUE TO NONUNION. THERE WAS ONE 3.5 LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE WAS BROKEN. ALSO, 3.5 LOCKING SCREW BROKE DURING REMOVAL. ALL HARDWARE WAS REMOVED EXCEPT FOR THE FRAGMENT OF THE BROKEN LOCKING SCREW. A STRYKER PLATE WAS USED TO REVISE. THE DATE OF THE ORIGINAL IMPLANT WAS ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME AND THE PATIENT CONSEQUENCE WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: 3.5 LCP DISTAL HUMERUS PLATE (PART # 02.104.008, LOT # UNKNOWN, QUANTITY 1); UNKNOWN CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 7); UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4); THIS REPORT IS FOR ONE (1) 3.5MM LCP RECONSTRUCTION PLATE 12 HOLES/168MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT CAPTURES THE POST-OPERATIVE EVENT WHERE THE PLATE BROKE POST-OPERATIVELY WHILE (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT WHERE THE SCREW BROKE DURING REMOVAL.

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8759161 ↗
• InjuryJan 19, 2018Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN 12 HOLE 3.5MM LOCKING COMPRESSION (LCP) RECONSTRUCTION PLATE. THE PLATE WAS DISCOVERED TO HAVE BEEN BROKEN THROUGH AN X-RAY TAKEN ON AN UNKNOWN DATE. THE DATE OF THE ORIGINAL CLAVICLE OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS (B)(6) 2017. THE PLATE WAS REMOVED WITH NO DELAY IN SURGERY OR REPORTED HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7205863 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,