NA 212.128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982152022), received between Sep 15, 2021 and Sep 15, 2021 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K000684, K072095); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY DUE TO NONUNION AND A BENT PLATE. THE REVISION SURGERY WAS SCHEDULED FOR LATER THAT DAY. PATIENT HAD A NONUNION OF A TIBIA PLATEAU FRACTURE. ORIGINAL FRACTURE WAS OF THE PROXIMAL TIBIA TREATED WITH A 3.5MM LCP PROXIMAL TIBIA PLATE AND ASSOCIATED 3.5MM LOCKING SCREWS. THE PATIENT REQUIRED A REVISION SURGERY DUE TO PAIN AND BOWING OF THE TIBIA. THE PLATE AND ALL SCREWS WERE REMOVED. THE FRACTURE WAS PROPERLY REDUCED, AND A TIBIA NAIL X WAS IMPLANTED. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. PATIENT EXPERIENCED PAIN AND DEFORMITY. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) 3.5 LOCKING SCREW SLF-TPNG SD RECESS 80. THIS REPORT IS 9 OF 10 FOR (B)(4).

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

  MAUDE report 12477829 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY DUE TO NONUNION AND A BENT PLATE. THE REVISION SURGERY WAS SCHEDULED FOR LATER THAT DAY. PATIENT HAD A NONUNION OF A TIBIA PLATEAU FRACTURE. ORIGINAL FRACTURE WAS OF THE PROXIMAL TIBIA TREATED WITH A 3.5MM LCP PROXIMAL TIBIA PLATE AND ASSOCIATED 3.5MM LOCKING SCREWS. THE PATIENT REQUIRED A REVISION SURGERY DUE TO PAIN AND BOWING OF THE TIBIA. THE PLATE AND ALL SCREWS WERE REMOVED. THE FRACTURE WAS PROPERLY REDUCED, AND A TIBIA NAIL X WAS IMPLANTED. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. PATIENT EXPERIENCED PAIN AND DEFORMITY. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) 3.5 LOCKING SCREW SLF-TPNG SD RECESS 80. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12477812 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K072095. 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,