LCP SD242.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982003638), received between Jan 5, 2017 and Oct 12, 2023 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K040588); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EVENT OCCURRED INTRA-OP WHERE AN 8.5 REAMER BROKE OFF IN THE PATIENT. THE INTERNAL CAPTURE ALSO BROKE INSIDE THE PATIENT FOR TWO OF THE CAPTURES; IT WAS UNSURE IF IT HAPPENED DUE TO THE PATIENT'S GOOD BONE. ON THE CONTRALATERAL SIDE, A DORSAL SPANNING PLATE WAS IMPLANTED AND THE LOCKING SCREW DID NOT LOCK. THE PATIENT WAS NOT CHARGED. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919174 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, PLATE WAS REMOVED AFTER 6 MONTHS. THE PLATE CAUSED A METACARPAL FRACTURE. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE(1) DEVICE 2.4MM LCP STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 14851016 ↗
• InjuryFeb 11, 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 SURGEON PLANNED TO REMOVE A 2.4 LCP WRIST SPANNING STRAIGHT PLATE FROM A WRIST. NO COMPLAINTS OR ADVERSE EVENTS WERE REPORTED. THIS REPORT INVOLVES (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13516127 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY OF THE LCP STRAIGHT WRIST PLATE. THERE WAS NO ALLEGATION AGAINST THE IMPLANT. IT WAS STATED THIS WAS A STANDARD REMOVAL AND THE PATIENT WAS EXPERIENCING CREPITUS. THE DATE OF THE ORIGINAL IMPLANT SURGERY IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13018961 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT A HARDWARE REMOVAL FOR WRIST FUSION DUE TO NON-UNION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS REPORTED AS SOFT TISSUE REPAIR. THIS REPORT IS FOR ONE (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12636349 ↗
• InjurySep 22, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE 2.4MM LCP STRAIGHT WRIST PLATE WAS BROKEN AND IT NEEDS TO BE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW LONG THE PLATE HAS BEEN BROKEN. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12515544 ↗
• InjuryJan 27, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENTS PLATE BROKE. THE HARDWARE REMOVAL OF A BROKEN 2.4 LCP STRAIGHT WRIST WAS SCHEDULED FOR (B)(6) 2021. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 6). THIS REPORT INVOLVES ONE (1) 2.4MM LCP® STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11237294 ↗
• MalfunctionDec 16, 2020Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) LEFT COMMINUTED ARTICULAR DISTAL RADIUS FRACTURE WITH SPANNING PLATE FIXATION ON (B)(6) 2020. THE PLAN WAS TO REMOVE THE PLATE AT THE END OF NOVEMBER BUT WHEN SHE WENT TO HER FOLLOW-UP APPOINTMENT ON NOVEMBER 13, 2020, SHE STATED THAT SHE HEARD A POP ABOUT A WEEK PRIOR AND HAD SOME PAIN AND SWELLING IN THE WRIST AREA. THE X-RAY REVEALED A BROKEN PLATE. DISCOVERED DURING PATIENT FOLLOW-UP BY X-RAY IN THE OFFICE ON NOVEMBER 13, 2020. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) 2.4MM LCP® STRAIGHT WRIST PLATE 170MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023682 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN AN UNKNOWN DATE DUE TO ADDITIONAL FRACTURES. THE ORIGINAL SURGERY OCCURRED (B)(6) 2020. ONE (1) LOCKING COMPRESSION PLATE (LCP) STRAIGHT WRIST PLATE AND SIX (6) SCREWS WERE TEMPORARILY REMOVED TO ACCESS ANOTHER FRACTURE FOR REPAIR AND WERE REINSERTED AT THE END OF THE CASE. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10477146 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A REMOVAL OF 2.4MM LOCKING COMPRESSION PLATE (LCP) STRAIGHT WRIST PLATE 170MM DUE TO MALUNION OF THE BONE ON (B)(6) 2020. THE INITIAL DISTAL RADIUS FRACTURE WAS REPAIRED ON (B)(6) 2020 WITH A 2.4 LCP STRAIGHT WRIST PLATE AND A VOLAR VA DISTAL RADIUS PLATE. THE LUNATE FACET FRAGMENT WAS EXTREMELY DIFFICULT TO FIXATE AND IT WAS DETERMINED ON (B)(6) 2020 THAT THE SURGEON HAD REMOVED THE 2.4MM WRIST STRAIGHT PLATE AND USED A MINI FRAGMENT TO REATTEMPT IN FIXATING LUNATE FRAGMENT. PATIENT OUTCOME AND STATUS ARE UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10391120 ↗
• InjuryNov 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A BROKEN 2.4MM LOCKING COMPRESSION PLATE STRAIGHT WRIST PLATE DUE TO NON-COMPLIANT PATIENT. THE PLATE WAS REMOVED WITHOUT COMPLICATIONS. THERE WAS NO ADDITIONAL HARDWARE WAS PUT IN. THE PATIENT¿S DISTAL RADIUS APPEARED TO BE HEALED. THE PATIENTS BROKEN PLATE WAS REMOVED, BUT THEY DID NOT NEED REVISION SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9317518 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE BONE FRACTURED OUTSIDE OF PLATE AFTER THE MOST RECENT FALL. A WRIST SPANNING PLATE WAS APPLIED APPROXIMATELY SIX MONTHS AGO. THE PATIENT HAD FALLEN MULTIPLE TIMES. THE ONE (1) 2.4MM LOCKING COMPRESSION PLATE AND 6 UNKNOWN SCREWS WERE REMOVED AND THE METACARPAL WAS REDUCED AND FIXED. A VARIABLE ANGLE HAND PLATE WAS USED TO FIX THE METACARPAL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.4MM LCP® STRAIGHT WRIST PLATE 170MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8501818 ↗
• InjuryFeb 14, 2019Break; Break

  02/14/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STRAIGHT WRIST PLATE BROKE SEVERAL WEEKS AFTER THE CASE. THE SURGEON EMAILED THE SALES CONSULTANT THE PICTURE OF THE BROKEN PLATE. THE PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 9). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8339262 ↗
• InjuryJan 2, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF STRAIGHT WRIST PLATE DUE TO POST-OPERATIVE PLATE BREAKAGE. THE STRAIGHT WRIST PLATE WAS REPLACED WITH AN UNKNOWN HEADLESS COMPRESSION SCREW SHORT THREAD. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: CORTEX SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) THIS REPORT IS FOR A 2.4MM LCP® STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8209713 ↗
• InjuryNov 30, 2018Break; Break

  EVENT : IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL PROCEDURE DUE TO LOCKING COMPRESSION PLATE (LCP) STRAIGHT WRIST PLATE WAS BROKEN. THE BROKEN PLATE, SEVEN (7) VARIABLE ANGLE LOCKING SCREWS AND ONE (1) CORTEX SCREW WERE REMOVED. THIS HAPPENED AFTER IMPLANTATION OF DORSAL SPANNING PLATE APPROXIMATELY TWELVE (12) WEEKS AGO. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. UPDATED CONCOMITANT DEVICES REPORTED: 2.4 MM VARIABLE ANGLE LOCKING SCREWS, WITH T8 STARDRIVE RECESS (PART 02.210.112, LOT UNKNOWN, QUANTITY 7); 2.4 MM CORTEX SCREWS, 3.5 MM HEAD, SELF-TAPPING (PART 201.614, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 8121156 ↗
• InjuryOct 1, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A 2.4MM LOCKING COMPRESSION PLATE STRAIGHT WRIST PLATE IMPLANT, LOCKING SCREWS AND CORTEX SCREWS WERE REMOVED AFTER FIXATION FAILURE DUE TO BREAKAGE OF THE PLATE AT THE JOINT LINE. ON (B)(6) 2018, THE INITIAL SURGERY, WAS PERFORMED WHEREIN THE SURGEON IMPLANTED THE PLATE, LOCKING SCREW AND CORTEX SCREWS. ON (B)(6) 2018 RADIOLOGY IMAGES WERE TAKEN AND SHOWED A BREAKAGE OF PLATE. PATIENT STATUS UNKNOWN. HARDWARE WAS REMOVED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNKNOWN 2.4MM LOCKING SCREWS (PART/LOT NUMBER UNKNOWN, QUANTITY: 5). UNKNOWN 2.4MM CORTEX SCREW (PART/LOT NUMBER UNKNOWN, QUANTITY: 1). UNKNOWN 2.7MM CORTEX SCREWS (PART/LOT NUMBER UNKNOWN, QUANTITY: 2). THIS REPORT IS FOR ONE (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7923583 ↗
• InjuryJun 20, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2018, THE LOCKING COMPRESSION PLATE (LCP) STRAIGHT WRIST PLATE WAS NOTED TO BE BROKEN IN HALF AT THE MIDDLE COMBINATION HOLE. THE BREAK WAS REPORTED TO HAVE OCCURRED SIX WEEKS AFTER THE LCP WAS IMPLANTED ALONG WITH A VOLAR RIM PLATE ON (B)(6) 2018, TO TREAT A DISTAL RADIUS FRACTURE. THE DISTAL PORTION OF THE LCP AND THREE UNKNOWN SCREWS WERE REMOVED. THE PROXIMAL PORTION OF THE LCP ALONG WITH UNKNOWN SCREWS AND THE VOLAR RIM PLATE STAYED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. GOOD PATIENT OUTCOME WAS REPORTED. CONCOMITANT DEVICES: 2.4MM VA LOCKING SCREW STARDRIVE 12MM (PART: 02.210.112, LOT: UNKNOWN, QUANTITY: 1), 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 10MM (PART: 212.810, LOT: UNKNOWN, QUANTITY: 1), 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM (PART 201.762, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A 2.4MM LCP® STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7621231 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A SPANNING WRIST PLATE, ONE 2.4 LOCKING SCREW, AND SEVEN 2.4 CORTEX SCREWS ON (B)(6) 2018 DUE TO DELAYED UNION OF THE DISTAL RADIUS. THE NINE DEVICES WERE REMOVED AND A VARIABLE ANGLE (VA) 2 COLUMN PLATE WAS INSERTED ALONG WITH BONE GRAFTING FROM THE ILIAC CREST. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2017. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS OK. THIS COMPLAINT INVOLVES THREE DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

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

  MAUDE report 7430884 ↗
• InjuryApr 10, 2018Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018 DUE TO A BROKEN WRIST-SPANNING PLATE. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2016 FOLLOWING A ROLL-OVER MOTOR VEHICLE ACCIDENT. THE REMOVED HARDWARE INCLUDED: ONE PLATE, SIX 2.4 MM CORTEX SCREWS AND TWO 2.4 MM LOCKING SCREWS, ALL REMOVED SUCCESSFULLY. THIS COMPLAINT INVOLVES NINE (9) DEVICES. CONCOMITANT DEVICES: 2.4 MM CORTEX SCREWS (PART #: UNK, LOT #: UNK, QTY: 6), 2.4 MM LOCKING SCREWS (PART #: UNK, LOT #: UNK, QTY: 2).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7412718 ↗
• InjuryJan 2, 2018Break; Break

  IT WAS REPORTED THAT INITIALLY A PATIENT UNDERWENT FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF DISTAL RADIUS ON AN UNKNOWN DATE AND WAS IMPLANTED WITH WRIST PLATE. THE PLATE BROKE POSTOPERATIVE DUE TO NON-COMPLIANCE OF PATIENT. THE PATIENT RECEIVED EXTENSOR TENDON RUPTURES DUE TO HARDWARE FAILURE. HARDWARE REMOVAL OF BROKEN PLATE WAS PERFORMED ON AN UNKNOWN DATE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORTED. PATIENT OUTCOME REPORTED AS STABLE FOLLOWING SURGERY. THIS REPORT IS FOR ONE (1) 2.4MM LCP® STRAIGHT WRIST PLATE 170MM. (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7157337 ↗
• InjuryDec 18, 2017Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, PATIENT UNDERWENT SURGERY FOR OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL RADIUS. SUBSEQUENTLY IT WAS DISCOVERED THAT THE PLATE WAS BROKEN AND THERE WAS A NON-UNION. A HARDWARE REMOVAL AND REVISION OF THE WRIST WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN PLATE AND NON-UNION. REMOVED HARDWARE INCLUDED: THE BROKEN PLATE, AND ELEVEN INTACT SCREWS -ALL REMOVED WITHOUT INCIDENT. THE PATIENT WAS REVISED TO AN IDENTICAL PLATE, SCREWS AND BONE GRAFTING. THERE WERE NO REPORTED SURGICAL DELAYS, NO FRAGMENTS INVOLVED, NO ADDITIONAL MEDICAL INTERVENTION AND NO ADDITIONAL X-RAYS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICE REPORTED: CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 3), LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 8). THIS REPORT IS FOR ONE (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM. (B)(4).

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

  MAUDE report 7125496 ↗
• InjuryDec 4, 2017Break; Break

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN PROCEDURE THAT WAS PERFORMED THREE MONTHS AGO WHERE A PATIENT WAS IMPLANTED WITH A 2.4MM LOCKING COMPRESSION PLATE (LCP) STRAIGHT WRIST PLATE AND 8 SCREWS (COMBINATION OF 2.4 CORTICAL AND 2.7 CORTICAL SCREWS). POSTOPERATIVELY, THE PATIENT COMPLAINED OF PAIN. AN X-RAY WAS TAKEN ON AN UNKNOWN DATE AND IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, WHERE THE BROKEN PLATE AND EIGHT (8) INTACT SCREWS WERE REMOVED. THE PATIENT WAS NOT REVISED WITH NEW IMPLANTS. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT DEVICES REPORTED: 2.4MM CORTICAL SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN), 2.7MM CORTICAL SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4MM LCP STRAIGHT WRIST PLATE 170MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7080025 ↗
• InjuryJan 5, 2017Break; Break

  IT IS REPORTED PATIENT WAS IMPLANTED WITH A 2.4MM LOCKING COMPRESSION PLATE (LCP) STRAIGHT WRIST PLATE, FIVE (5) 2.4MM LOCKING SCREWS, AND FOUR (4) 2.4MM CORTEX SCREWS TO REPAIR A FRACTURE OF THE LEFT DISTAL RADIUS ON (B)(6) 2016. THIS PLATE, KNOWN AS A ¿BRIDGE¿ PLATE, IS TYPICALLY REMOVED AFTER THREE (3) MONTHS. DURING ROUTINE EXAMINATION ON DECEMBER 7, 2016, X-RAYS REVEALED PATIENT WAS NOT COMPLETELY HEALED BUT ALL HARDWARE WAS INTACT. PATIENT LATER COMPLAINED OF PAIN AND ADDITIONAL X-RAYS TAKEN ON (B)(6) 2016 REVEALED THE PLATE HAD BROKEN DIRECTLY IN THE CENTER OF THE PLATE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 WHERE SURGEON REMOVED ALL HARDWARE. ALL NINE (9) SCREWS WERE REPORTED TO BE INTACT AT THE TIME OF EXPLANT. PATIENT WAS NOT REVISED TO ADDITIONAL HARDWARE; SURGEON WILL INSTEAD APPLY A CAST. SURGEON REPORTS PATIENT IS NON-COMPLIANT AND A SMOKER, CONTRIBUTING TO THE DELAY IN HEALING. ALL HARDWARE WAS REMOVED EASILY AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT MEDICAL PRODUCTS REPORTED: 2.4MM LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 5), 2.4MM CORTEX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, Q

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 6227170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040588. One submission often covers many models, so check the product and lot details in each record.

• 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