LCP 245.061Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982169594), received between Aug 24, 2018 and Jan 27, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 DUE TO NON-UNION AND A BROKEN PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP RECONSTRUCTION PLATE 6 HOLES/84MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16253018 ↗
• InjuryAug 19, 2021Break; Break

  IT WAS REPORTED THAT, PATIENT HAD AN X-RAY OF A BROKEN PLATE, ONE(1) 3.5MM LCP PLATE, RECON 6 HOLE AND SEVEN(7) CORTEX SCREWS 3.5. SIX(6) EACH INSIDE PLATE CONSTRUCT AND 1 EACH OUTSIDE PLATE CONSTRUCT. REVISION SURGERY SCHEDULED FOR (B)(6) 2021. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREW 3.5 (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 7). THIS REPORT IS FOR ONE (1) 3.5 LCP RECONSTRUCTION PLATE 6 HOLES/84. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 12342851 ↗
• InjuryAug 11, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF TWO (2) PLATES, FIVE (5) UNKNOWN CORTEX SCREWS AND EIGHT (8) UNKNOWN LOCKING SCREWS DUE TO ONE OF THE PLATES WAS BROKEN. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 3.5MM LCP RECONSTRUCTION PLATE 6 HOLES/84MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12309942 ↗
• InjuryDec 24, 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE AND HARDWARE REMOVAL DUE TO NON-UNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH LOCKING COMPRESSION PLATE AND LOCKING SCREWS ON AN UNKNOWN DATE. THE PATIENT WAS NON-COMPLIANT TO POST-OPERATIVE INSTRUCTION CAUSING A NON-UNION AND REMOVAL OF HARDWARE. MEDICAL INTERVENTION REQUIRED THE REMOVAL OF HARDWARE AND RE-INSTRUMENTING. THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SCREWS.

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9516406 ↗
• InjuryNov 5, 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 HARDWARE REMOVAL DUE TO NON-UNION OF DISTAL TIBIA AND FIBULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES SEVENTEEN (17) DEVICES. THIS IS 2 OF 10 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9278949 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS LOOKING TO SEE WHAT METAL WAS IN THE PLATES THAT SHE HAD IMPLANTED APPROXIMATELY THIRTEEN (13) YEARS AGO. SHE STATED SHE RECENTLY HAD SWELLING IN HER ARMS AND WAS UNSURE IF THIS WAS RELATED TO HER AGE OR THE IMPLANTS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Reaction; Swelling

  MAUDE report 7814232 ↗

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,