LCP 223.561Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982157911), received between Jun 26, 2017 and Feb 24, 2022 — classified as 11 injuries.

1 other recall cover devices cleared under the same FDA submission (K000684, K082807); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM LCP PLATE 6 HOLES 85MM. THIS IS REPORT 14 OF 14 FOR PC-(B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13591208 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM LCP PLATE 6 HOLES 85MM. THIS IS REPORT 13 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13591196 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT FOR REMOVAL OF LOCKING COMPRESSION PLATE AND SIX (6) UNKNOWN CORTEX SCREWS DUE TO POLYTRAUMA WITH A BROKEN MIDSHAFT RADIUS FROM AN ATV ACCIDENT. THE NEW FRACTURE OCCURRED AT THE END OF THE OLD PLATE. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 3.5MM LCP PLATE 6 HOLES 85MM. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12325529 ↗
• InjuryJan 7, 2021Adverse 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 HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES 16 DEVICES. THIS REPORT IS FOR (1) 3.5MM LCP PLATE 6 HOLES 85MM. THIS REPORT IS 9 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132505 ↗
• InjuryAug 20, 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 REMOVAL OF THE 3.5MM LOCKING COMPRESSION PLATE (LCP) PLATE ALONG WITH THE TWO (2) UNKNOWN LOCKING SCREWS AND TWO (2) UNKNOWN CORTEX SCREWS DUE TO UNCOMFORTABLENESS IN THE WRIST . THE IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE PLATE AND FOUR (4) SCREWS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS NOT REVISED TO NEW DEVICES. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 6 HOLES 85MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 10434860 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF A FRACTURED ULNAR LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE AND AN UNKNOWN RADIAL PLATE, REPAIR OF NON-UNION RIGHT RADIUS AND ULNA USING A RADIAL METAPHYSEAL BONE GRAFT-MODIFIER 22, AND A TOCOLYSIS BRACHIORADIALIS TENDON WAS ALSO PERFORMED. INITIALLY, ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICES. THE PATIENT HAD A MOTOR VEHICLE CRASH (MVC) ON (B)(6) 2018 AND A FALL PRECEDING THE EVENT. AN X-RAY WERE TAKEN AND AN ANTERIOR-POSTERIOR (AP) AND LATERAL VIEWS OF THE RIGHT FOREARM AND WRIST WERE REVIEWED WHICH SHOWED AN INTERVAL CALLUS, RADIAL SHAFT FRACTURE, AND HARDWARE FAILURE TO MIDSHAFT OF THE ULNA PLATE WITH INTERVAL CALLUS. THERE WAS ALSO A CONCERN FOR DELAYED UNION. THUS, A RE-OPERATION WAS DONE WHEREIN THE FRACTURE OF NON-UNION WAS IDENTIFIED. FIRST, THE PLATE WAS EXPOSED PROXIMALLY AND DISTALLY ON THE ENTIRE LENGTH AND THE SURGEON NOTED THE FRACTURE OF THE PLATE THROUGH THE HOLE THAT WAS AT THE LEVEL OF THE NONUNION SITE. MOREOVER, AN ABUNDANT PERIOSTEAL BONE FORMATION ALONG THE PLATE WAS OBSERVED AND MORE SIGNIFICANTLY AT THE NONUNION SITE, BUT AFTER THE REMOVAL OF THE NEW

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

  MAUDE report 8794649 ↗
• InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT SCAPULA FOR FAILED FIXATION AND LOSS OF ANATOMIC REDUCTION, DUE TO PATIENT COMPLIANCE. THERE WAS NO REPORT OF MALFUNCTION WITH ANY OF THE DEVICES. A LOCKING COMPRESSION PLATE 6 HOLES, LCP RECONSTRUCTION PLATE 8 HOLES, TWO (2) 3.5MM UNKNOWN LOCKING SCREWS, NINE (9) 3.5MM UNKNOWN CORTEX SCREWS AND ONE (1) 2.7MM UNKNOWN CORTEX SCREW WERE REMOVED. BONE LOSS REQUIRED FIBULAR STRUT ALLOGRAFT PLACEMENT AND INFUSE BONE MORPHOGENETIC PROTEINS (BMP). DURING REVISION, PATIENT WAS IMPLANTED WITH NEW FIXATION. ORIGINAL IMPLANT DATE IS UNKNOWN, LESS THAN ONE YEAR PRIOR TO THE REVISION SURGERY. THE PLATES WERE INTENTIONALLY BENT OR CONTOURED DURING INITIAL IMPLANTATION. SURGICAL DELAY IS UNKNOWN. PROCEDURE WAS SUCCESSFULLY COMPLETED, AND PATIENT OUTCOME WAS AS PLANNED. THIS REPORT IS FOR ONE (1) LOCKING COMPRESSION PLATE, 6 HOLES. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7964863 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO REVISION ON (B)(6) 2018, TO REMOVE THE FOLLOWING HARDWARE: ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE 6 HOLES, ONE (1) TITANIUM LOCKING SCREW 60MM, ONE (1) TITANIUM LOCKING SCREW 76MM, ONE (1) TITANIUM LOCKING SCREW 30MM, ONE (1) TITANIUM LOCKING SCREW 50MM AND ONE (1) CORTEX SCREW SELF-TAPPING, DUE TO OSTEOMYELITIS. THE HARDWARE WAS ORIGINALLY IMPLANTED FOR A FRACTURE REPAIR SURGERY TO THE RIGHT TIBIA ON AN UNKNOWN DATE IN 2017. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7758149 ↗
• InjuryFeb 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013 (APPROXIMATE DATE), PATIENT ASSISTED A FRIEND BY LOADING A MOTORCYCLE ON TO A TRAILER WHEN THE MOTORCYCLE FELL ON TO HIS LOWER RIGHT LEG. PATIENT SUSTAINED A DISTAL TIBIA AND FIBULA FRACTURE ABOVE THE RIGHT ANKLE. PATIENT UNDERWENT SURGERY ON (B)(6) 2013 (APPROXIMATE DATE) TO IMMOBILIZE THE LOWER RIGHT LEG/ANKLE FOR THE HEALING PROCESS AND WAS IMPLANTED WITH SYNTHES LOCKING SMALL FRAGMENT SET WHICH CONSISTED OF PLATES AND SCREWS. IN (B)(6) 2015 PATIENT NOTICED PAIN AND SWELLING AND A CURVATURE THAT BEGAN TO DEVELOP IN HIS LOWER RIGHT LEG/ANKLE AND WENT TO THE EMERGENCY ROOM IN (B)(6) 2015 AT ONE HOSPITAL AND THEN TO ANOTHER HOSPITAL DUE TO THE PAIN AND THE DEFORMITY DEVELOPING IN HIS LOWER RIGHT LEG/ANKLE. X-RAYS TAKEN ON (B)(6) 2015 (APPROXIMATE DATE) AND AGAIN ON (B)(6) 2015 (APPROXIMATE DATE) REVEALING A CURVATURE/DEFORMITY . IT WAS NOTED THAT THE PLATE WAS BROKEN ALONG WITH MANY OF THE SCREWS AND THERE WAS A NONUNION OF THE TIBIA AND FIBULA FRACTURES. AFTER THE EMERGENCY ROOM VISIT, PATIENT WENT TO A MEDICAL CENTER FOR FURTHER EVALUATION. PATIENT WAS INFORMED ABOUT UNDERGOING REVISION SURGERY TO REMOVE THE BROKEN HARDWARE, RESET THE BROKEN TI

  Patient problems: Unspecified Infection

  MAUDE report 7295388 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD ORIGINAL SURGERY PERFORMED ON (B)(6) 2014. PATIENT WAS REVISED ON (B)(6) 2015 DUE TO NON-UNION. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2018 DUE TO NONUNION OF HUMERUS AND ONE BROKEN 4.0MM LOCKING SCREW. DURING REVISION SURGERY THE HEAD OF THE BROKEN SCREW WAS REMOVED AND THE SHAFT OF THE SCREW WAS LEFT INSIDE THE PATIENT. ALSO, ONE (1) 4.5MM NARROW LCP PLATE 8 HOLES/152MM, THREE (3) 4.5MM CORTEX SCREWS, THREE (3) 3.5MM CORTEX SCREWS, ONE (1) 3.5MM LCP PLATE 6 HOLES 85MM, TWO (2) 3.5MM LOCKING SCREWS AND TWO (2) 4.0MM LOCKING SCREWS WERE REMOVED INTACT. THE FRACTURE ENDS WERE SHORTENED AND THE PATIENT WAS REPLATED WITH A 7 HOLE 4.5MM BROAD PLATE (VIVIGEN BONE GRAFT). THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND WITHOUT ANY OTHER MEDICAL INTERVENTION REQUIRED. PATIENT WAS REPORTED TO BE OKAY AFTER THE SURGERY. LATER, IT WAS INFORMED BY THE HOSPITAL THAT THE INTRA-OP CULTURES CAME BACK POSITIVE FROM THE DAY OF SURGERY. THE DOCTOR HAS DECIDED TO USE ANTIBIOTICS FOR TREATMENT OF THE INFECTION. THIS REPORT ADDRESSES SECOND REVISION SURGERY DUE TO BROKEN SCREW AND INFECTION. THE FIRST REVISION SURGERY DUE TO NON-UNION HAS BEEN C

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7287471 ↗
• InjuryJun 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS UNABLE TO BE CONFIRMED IF CULTURES WERE TAKEN OR WHAT THE RESULTS OF THE CULTURES WERE.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 6668020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K082807. 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,