NA 212.115Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982151896), received between Mar 1, 2019 and Sep 15, 2021 — classified as 5 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 5 most recent of 5 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 LCKNG SCREW SLF-TPNG W/SD(TM) REC 36. THIS REPORT IS 10 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12477830 ↗
• 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 LCKNG SCREW SLF-TPNG W/SD(TM) REC 36. THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12477819 ↗
• 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 SIXTEEN (16) DEVICES. THIS REPORT IS FOR (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 36MM. THIS REPORT IS 6 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132528 ↗
• InjuryJan 30, 2020Adverse 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 AN EMERGENT INCISION AND DRAINAGE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT TIBIA DUE TO OSTEOMYELITIS AND INFECTION. ON AN UNKNOWN DATE THE PATIENT FELL WITH HER LEG WENT BEHIND HER, FRACTURING HER TIBIA. SHE ALSO HAD AN OPEN DEHISCENCE OF HER SURGICAL WOUND ON THE KNEE. DUE TO THE BEND OF THE KNEE AND THE SPLIT OF THE SKIN, SHE HAS BEEN BLEEDING AND HAS AN OPENING ON HER KNEE REPLACEMENT. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPEN TREATMENT OF TIBIAL SHAFT FRACTURE ON THE RIGHT SIDE WITH AN INTERNAL FIXATION WITH PLATE; A SECONDARY CLOSURE OF THE SURGICAL WOUND DEHISCENCE, AND AN EXTENSIVE AND COMPLICATED 8CM AND ARTHROTOMY KNEE WITH EXPLORATION AND DRAINAGE OF THE RIGHT KNEE, WHERE THE KNEE REPLACEMENT IS LOCATED.. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 36MM. THIS IS REPORT 2 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9648662 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: ALLERGY TESTING WILL NOT BE COMPLETED UNTIL EARLY MAY, 2019. IT IS A 4 ¿ 6 STEP PROCESS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8383742 ↗

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,