LCP 247.372Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982170873), received between Dec 14, 2017 and Dec 10, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K063049); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6), 2021, PATIENT UNDERWENT A ORIF OF A DISTAL ULNA PROCEDURE. THE PATIENT BEGAN HAVING A HEART ATTACK, THE SURGEON WAS QUICKLY ABLE TO GET 6 SCREWS IN THE PLATE BEFORE HAVING TO SWIFTLY CLOSE THE WOUND IN ORDER TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL. IT WAS NOTICED THAT THE SCREW WAS TOO LONG, AND THE SCREW HEAD STRIPPED OUT AND HE WAS UNABLE TO CHANGE THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES NOTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.7MM LCP(TM) PLATE 8 HOLES/76MM THIS IS REPORT 1 OF 2 OR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977666 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PROCEDURE, THE SURGEON FOUND THE ANTEROLATERAL PLATE WAS TOO BULKY AND NOT ABLE TO LOCK THE SCREW. THE SCREW APPEARED TO BE AT A DIFFERENT ANGLE THAN THE NOMINAL ANGLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.7 MM LCP(TM) PLATE 8 HOLES/76 MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708069 ↗
• InjuryMar 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 REMOVAL PROCEDURE DUE TO A NON-UNION OF THE MID-SHAFT HUMERUS. DURING THE PROCEDURE THE 9-HOLE 4.5 NARROW LOCKING COMPRESSION PLATE (LCP) AND ALL OF ITS EIGHT (8) 4.5MM CORTICAL SCREWS WERE EXPLANTED. ALSO REMOVED DURING THE PROCEDURE WAS THE 2.7 8-HOLE STRAIGHT LOCKING COMPRESSION PLATE (LCP) AND ALL OF ITS SIX (6) 2.7 CORTICAL SCREWS. IT IS UNKNOWN WHAT DEVICE WAS THE PATIENT REVISED TO AFTER THE ORIGINAL IMPLANTS WERE REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS REPORT IS FOR (1) 2.7MM LCP(TM) PLATE 8 HOLES/76MM THIS IS 1 OF 10 FOR REPORT (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9793777 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JULY 11, 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A MALUNION AND INFECTION. MOREOVER, THE PATIENT HAD EXPERIENCED DELAYED HEALING. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH ONE (1) 3.5 MM LOCKING COMPRESSION PLATE (LCP) LOW BEND MEDIAL DISTAL TIBIAL PLATE, THREE (3) UNKNOWN 3.5 MM LOCKING SCREWS, TWO (2) UNKNOWN 3.5 MM CORTEX SCREWS, ONE (1) 2.7 MM LCP PLATE, FOUR (4) UNKNOWN 2.7 MM CORTEX SCREWS AND TWO (2) UNKNOWN 2.7 MM LAG SCREWS ON AN UNKNOWN DATE. DURING REVISION, ALL HARDWARE WERE SUCCESSFULLY REMOVED AND THE PATIENT WAS REVISED WITH 3.5 MM CORTEX SCREW WITH WASHER AND A VARIABLE-ANGLE (VA) ANTEROMEDIAL DISTAL TIBIA PLATE. PATIENT OUTCOME IS UNKNOWN. THE COMPLAINT INVOLVES 13 DEVICES. DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT WILL BE CAPTURED UNDER 2 SEPARATE COMPLAINTS : (B)(4). (B)(4) CAPTURES THE POST-OP EVENT DUE TO MALUNION AND INFECTION WHILE (B)(4) CAPTURES THE INTRAOPERATIVE EVENT WHEREIN THE TIP OF THE TWO (2) STARDRIVE SCREWDRIVER SHAFTS WERE TWISTED ON FINAL TIGHTENING OF THE SCREWS. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS 2 OF 9 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8876293 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A LOCKING COMPRESSION PLATE (LCP) PLATE, SIX (6) UNKNOWN CORTEX SCREWS, AND AN UNKNOWN LOCKING SCREW ON A DISTAL ULNA FRACTURE. THIS WAS DUE TO NON-UNION AND THE PLATE POSITIONED INCORRECTLY IN THE DISTAL RADIAL ULNAR JOINT. THE PLATE WAS REMOVED, THE EDGES OF THE FRACTURE WERE CORRECTED, AND A NEW LCP PLATE WAS IMPLANTED. ALL HARDWARE WAS REMOVED SUCCESSFULLY. THE ORIGINAL SURGERY WAS AN OPEN FRACTURE ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.7MM LCP(TM) PLATE 8 HOLES/76MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8181532 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OF ONE (1) 2.7 MM LOCKING COMPRESSION (LCP) PLATE AND SIX (6) 2.7 MM CORTICAL SCREWS WAS PERFORMED ON (B)(6) 2017 UPON DISCOVERING A NON-UNION. THE PATIENT WAS IMPLANTED WITH A 2.7 MM LCP PLATE AND SIX 2.7 MM CORTICAL SCREWS FOR AN ULNA SHORTENING PROCEDURE ON AN UNKNOWN DATE. THE PATIENT WAS LATER DISCOVERED TO HAVE A NON-UNION FOLLOWING THE INITIAL SURGERY, DUE TO WHICH, OPEN REDUCTION INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2017 AND THE ORIGINALLY IMPLANTED CONSTRUCTS WERE REMOVED. THE LCP PLATE AND THE CORTICAL SCREWS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW LCP PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS FINE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7119812 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen