LCP 224.591Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982158529), received between Apr 26, 2017 and Mar 5, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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. How this data works · Data updated Oct 13, 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.

• 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)4.5MM NARROW LCP® PLATE 9 HOLES/170MM. THIS IS 2 OF 10 FOR REPORT (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9793769 ↗
• InjuryMar 21, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF NARROW LOCKING COMPRESSION PLATE (LCP) DUE TO BROKEN PLATE AND REPLACED WITH A NEW LARGE FRAGMENT PLATE. THE SURGEON PERFORMED THE INITIAL SURGERY ON (B)(6) 2018 FOR A TIBIA AND FIBULA FRACTURE. HE USED NARROW LOCKING COMPRESSION PLATE (LCP) ALONG WITH FOUR (4) LOCKING SCREWS AND FIVE (5) CORTEX SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4); UNK - SCREWS: CORTEX: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 5). THIS REPORT IS FOR ONE (1) 4.5MM NARROW LCP® PLATE 9 HOLES/170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8440443 ↗
• InjuryMar 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF PLATE AND SCREWS ON (B)(6) 2019, DUE TO BROKEN PLATE AND PAIN ON THE LEFT FEMUR. THE PATIENT SHOWED UP AT THE CLINIC WITH LEG PAIN. AN X-RAY WAS DONE ON (B)(6) 2019, AND IT WAS FOUND OUT THAT THE PLATE WAS BROKEN. THE PATIENT HAD AN ORIGINAL IMPLANT OF ONE (1) NARROW LOCKING COMPRESSION PLATE, AND ONE (1) 5.0MM/32MM LOCKING SCREW SELF-TAPING, THREE (3) 5.0MM/34MM LOCKING SCREW SELF-TAPING, THREE (3) 5.0MM/36MM LOCKING SCREW SELF -TAPING, ONE (1) 5.0MM/38MM LOCKING SCREW SELF -TAPING ON (B)(6) 2018. THE PLATE AND SCREWS WERE COMPLETELY REMOVED WITHOUT DELAY. AND REPLACED WITH 4.5 MM LOCKING COMPRESSION PLATE BROAD AND (3) 4.5MM CORTEX SCREWS AND (6) 5.0MM LOCKING SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS REPORTED: 5.0MM LOCKING SCREW SELF-TAPING WITH T25 STARDRIVE RECESS 32MM (PART#212.210,LOT#UNKNOWN,QUANTITY 1), 5.0MM LOCKING SCREW SELF -TAPING WITH T25 STARDRIVE RECESS 34MM (PART#212.211, LOT#UNKNOWN, QUANTITY 3), 5.0MM LOCKING SCREW SELF -TAPING WITH T25 STARDRIVE RECESS RECESS 36MM (PART#212.212, LOT#UNKNOWN, QUANTITY 3), 5.0MM LOCKING SCREW SELF -TAPING WITH T2

  Patient problems: No Code Available; Pain

  MAUDE report 8387849 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A REVISION SURGERY ON (B)(6) 2015 FOR NONUNION OF HUMERUS. THE ORIGINAL SURGERY WAS DONE ON (B)(6) 2014. DURING THE REVISION SURGERY, ONE PLATE, SEVEN 4.5 MM CORTEX SCREWS AND ONE 5.0 MM LOCKING SCREW WERE REMOVED INTACT. THE PATIENT WAS IMPLANTED WITH ONE 4.5 MM NARROW LCP® PLATE 8 HOLES/152 MM, THREE 4.5 MM CORTEX SCREWS, THREE 4.0 MM CORTEX SCREWS, ONE 3.5 MM LCP PLATE 6 HOLES 85 MM HOLES/152 MM, THREE 3.5 MM CORTEX SCREWS AND TWO 3.5 MM LOCKING SCREWS. THE INTRA-OP CULTURES CAME BACK POSITIVE FROM THE DAY OF SURGERY. NO OTHER DETAILS ARE AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7216678 ↗
• InjuryJul 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION DUE TO NON-UNION OF THE HUMERUS ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT PRESENTED WITH MULTIPLE ORTHOPEDIC INJURIES INCLUDING RIGHT HUMERUS, RIGHT ANKE PILON/DISLOCATION AND LEFT DISTAL FEMUR FRACTURES. AT THE TIME OF INITIAL INJURY, THE HUMERUS WAS REPAIRED WITH A 9-HOLE LOCKING COMPRESSION (LCP) LARGE FRAGMENT PLATE AND SCREWS. AFTER OBSERVING VIA RADIOGRAPHIC IMAGING THAT THE PLATE AT THE TIME WAS IMPLANTED WAS OFF-PLANE TO THE BONE PROXIMALLY, THE SURGEON DECIDED TO CUT THE PLATE INSITU USING A MIDAS REX LIKE DEVICE. SUBSEQUENTLY, THE HUMERUS DID NOT HEAL. DURING THE (B)(6) 2017 PROCEDURE, ALL THE OLD HARDWARE WAS REMOVED AND THE NEXT COUPLE PHASES OF BONE HEALING WILL BE STAGED UTILIZING THE "MASQUELET TECHNIQUE". TEMPORARY FIXATION OF THE HUMERUS USING A LONG LCP PROXIMAL HUMERUS PLATE AND ANTIBIOTIC CEMENT WAS PERFORMED. THE SURGEON PLANS TO COME BACK IN SEVERAL WEEKS TO REMOVE THE PROXIMAL HUMERUS PLATE AND CEMENT, AND THEN PERFORM ANOTHER PROCEDURE WITH BONE GRAFT AND DEFINITIVE FIXATION. ALL HARDWARE WAS REMOVED INTACT AND WITHOUT ANY SURGICAL DELAY. REMOVED HARDWARE INCLUDED ONE PLATE AND EIGHT (8) SCREWS. IT WAS NO

  Patient problems: Impaired Healing

  MAUDE report 6683934 ↗
• InjuryApr 26, 2017Break; Break

  IT WAS REPORTED PATIENT UNDERWENT REVISION SURGERY DUE TO A NONUNION AND BROKEN 4.5MM NARROW LOCKING COMPRESSION PLATE (LCP) PLATE. PATIENT HAD THE INITIAL OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE LEFT FEMORAL SHAFT ON (B)(6) 2017 FOR A FRACTURE. PATIENT WAS IMPLANTED WITH ONE 4.5MM NARROW LCP PLATE AND SIX LARGE FRAGMENT CORTEX SCREWS OF VARIOUS SIZES. IT IS UNKNOWN HOW THE BROKEN PLATE AND NONUNION WERE DISCOVERED. IT IS UNKNOWN IF PATIENT REPORTED ANY ADVERSE EVENT. IT IS UNKNOWN IF THERE WERE ANY REPORTED ISSUES DURING INITIAL SURGERY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. THE PLATE BROKE IN TWO PIECES. IT WAS A CLEAN BREAK AND NO FRAGMENTS WERE GENERATED. THE PLATE AND SCREWS WERE EASILY REMOVED AND DID NOT REQUIRE ADDITIONAL INTERVENTION. THE SCREWS WERE INTACT. PATIENT WAS REVISED TO ADOLESCENT LATERAL ENTRY FEMORAL NAIL. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. NO OTHER MEDICAL INTERVENTION REQUIRED. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THERE IS 1 DEVICE IN THIS COMPLAINT CONCOMITANT MEDICAL PRODUCTS: LARGE FRAGMENT CORTEX SCREW (VARIOUS SIZES) (PART NUMBERS: 214.8XX, LOT NUMBER UNKNOWN, QUANTITY 6). THIS REPORT IS 1 OF 1

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6524801 ↗