NA 212.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982151902), received between Dec 11, 2017 and Sep 15, 2021 — classified as 6 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 6 most recent of 6 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 TEN(10) DEVICES. THIS REPORT IS FOR (1) 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 38 THIS REPORT IS 6 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12477817 ↗
• 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 38MM. THIS IS REPORT 3 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9648949 ↗
• InjuryApr 8, 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 REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT PROXIMAL HUMERUS DUE TO NONUNION. THE FOLLOWING HARDWARE WAS REMOVED: ONE (1) LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE-STANDARD 3H HEAD SHAFT. ONE (1) CORTEX SCREW SELF-TAPPING 34MM. ONE (1) CORTEX SCREW SELF-TAPPING 30MM. TWO (2) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 52MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 40MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 48MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 38MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 50MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 46MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 32MM. HARDWARE WAS ORIGINALLY IMPLANTED ON DECEMBER 23, 2017. ALL HARDWARE WAS REMOVED SUCCESSFULLY AND INTACT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.5MM LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS(TM) 38MM. THIS IS REPORT 7 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8491978 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A TIBIAL FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION RECONSTRUCTION PLATE 10 HOLES/140MM, THREE (3) 3.5MM LOCKING SCREWS WITH RECESS 38MM AND ONE (1)3.5MM LOCKING SCREW WITH RECESS 44MM. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT WAS PRESENTED WITH EXPOSURE OF HARDWARE AT THE TIBIA BONE. THE SOFT TISSUE HAD ERODED AROUND THE CONSTRUCT IMPLANT SITE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS. THE TIBIAL BONE FRACTURED HAS HEALED, SO NO NEW BONE FIXATION WAS NEEDED. NO INFECTION WAS REPORTED AND IT WAS OBSERVED THAT THE IMPLANTS WERE IN GOOD CONDITION WHEN REMOVED. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE¿ RECESS 38MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7105241 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A TIBIAL FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION RECONSTRUCTION PLATE 10 HOLES/140MM, THREE (3) 3.5MM LOCKING SCREWS WITH RECESS 38MM AND ONE (1)3.5MM LOCKING SCREW WITH RECESS 44MM. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT WAS PRESENTED WITH EXPOSURE OF HARDWARE AT THE TIBIA BONE. THE SOFT TISSUE HAD ERODED AROUND THE CONSTRUCT IMPLANT SITE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS. THE TIBIAL BONE FRACTURED HAS HEALED, SO NO NEW BONE FIXATION WAS NEEDED. NO INFECTION WAS REPORTED AND IT WAS OBSERVED THAT THE IMPLANTS WERE IN GOOD CONDITION WHEN REMOVED. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE¿ RECESS 38MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7105151 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A TIBIAL FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION RECONSTRUCTION PLATE 10 HOLES/140MM, THREE (3) 3.5MM LOCKING SCREWS WITH RECESS 38MM AND ONE (1)3.5MM LOCKING SCREW WITH RECESS 44MM. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT WAS PRESENTED WITH EXPOSURE OF HARDWARE AT THE TIBIA BONE. THE SOFT TISSUE HAD ERODED AROUND THE CONSTRUCT IMPLANT SITE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS. THE TIBIAL BONE FRACTURED HAS HEALED, SO NO NEW BONE FIXATION WAS NEEDED. NO INFECTION WAS REPORTED AND IT WAS OBSERVED THAT THE IMPLANTS WERE IN GOOD CONDITION WHEN REMOVED. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE¿ RECESS 38MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7104947 ↗

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,