NA 212.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982151773), received between Feb 5, 2018 and Nov 9, 2021 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) WITH FIVE (5) CORTEX SCREWS AND ONE (1) LOCKING SCREW DUE TO NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 33.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12779514 ↗
• MalfunctionJan 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AN ORDER OF SCREWS WERE RECEIVED WITH EMPTY PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147602 ↗
• MalfunctionMay 1, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FACILITY TOOK A PICTURE OF THE IMPLANTS SHIPPED TO SHOW THE ORDER CONFIRMATION, HOWEVER, THE IMPLANTS WERE NOT INSIDE THE BAG AND THE BAG WAS NOT DAMAGED. THE FACILITY PLACED A STANDARD ORDER AND SIX (6) ITEMS WERE SHIPPED WITH A QUANTITY OF ONE (1) ON EACH ITEM AND NONE OF THOSE ITEMS WERE IN THE BAG. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10018797 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN. THERE WERE (1) LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE WERE REMOVED. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL SIX DEVICES. THIS COMPLAINT INVOLVES TEN 10 OF THE 16 DEVICES. THIS COMPLAINT IS FOR ONE 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM. THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7976008 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER QUALITY UNIT RECEIVED A USER FACILITY REPORT FORWARDED FROM (B)(6) HOSPITAL; THIS REPORT IS AGAINST USER FACILITY MEDWATCH REPORT (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE IN WHICH THE 2.7 MM/3.5 MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL FIBULA PLATE AND THIRTEEN (13) SCREWS FOR A CLAVICLE FRACTURE ON (B)(6) 2017. ON UNKNOWN DATE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ELEVEN (11) OF THE SCREWS AND THE PLATE. IT IS UNKNOWN WHY TWO (2) OF THE SCREWS REMAIN IMPLANTED. SURGERY WAS COMPLETED. PATIENT STATUS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 3.5 MM LOCKING SCREW 14 MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7434702 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT MIDSHAFT RADIUS FRACTURE ON AN UNKNOWN DATE. A 3.5MM 10 HOLE LOCKING COMPRESSION PLATE (LCP) AND NINE (9) SCREW WERE IMPLANTED AT THAT TIME. ON AN UNKNOWN DATE, PATIENT DEVELOPED AN ABSCESS INFECTION ON THE LEFT FOREARM. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS SUCCESSFULLY REMOVED. DURING THE REMOVAL PROCEDURE, ONE (1) CORTEX SCREW WAS NOTED TO BE BROKEN, ALSO REMOVED SUCCESSFULLY. (B)(4).

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 7332900 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT MIDSHAFT RADIUS FRACTURE ON AN UNKNOWN DATE. A 3.5MM 10 HOLE LOCKING COMPRESSION PLATE (LCP) AND NINE (9) SCREW WERE IMPLANTED AT THAT TIME. ON AN UNKNOWN DATE, PATIENT DEVELOPED AN ABSCESS INFECTION ON THE LEFT FOREARM. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS SUCCESSFULLY REMOVED. DURING THE REMOVAL PROCEDURE, ONE (1) CORTEX SCREW WAS NOTED TO BE BROKEN, ALSO REMOVED SUCCESSFULLY. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 7332748 ↗
• InjuryFeb 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT PROCEDURE FOR OSTEOSYNTHESIS DISTAL TIBIA AND RIGHT FIBULA. REPORTEDLY, LCP 3.5 MM PLATES FOR DISTAL TIBIA IN TITANIUM AND STEEL WITH THEIR RESPECTIVE SCREW RACKS WERE SENT FOR THIS PROCEDURE. THE TIBIAL OSTEOSYNTHESIS PROCEDURE WAS STARTED WITH A VERY DISTAL FRACTURE. A 6-HOLE RIGHT MEDIAL PLATE WAS PLACED IN TITANIUM AND FIXATION WAS STARTED IN THE DISTAL PART. THE DOCTOR NEEDED A BLOCKED SCREW OF 3.5 MM OF 14 MM BUT THE SCREWS IN TITANIUM RACK STARTED FROM 26 MM UP TO 60 MM IN LENGTH; THE DOCTOR WAS UPSET AND PLACED A 3.5 MM X 14 MM LOCKED SCREW IN STEEL, SINCE STEEL SCREWS COME FROM 10 MM TO 60 MM IN LENGTH. FIXATION WAS CONTINUED AND IN THE BODY OF THE PLATE THE DOCTOR DECIDED TO PLACE A BLOCKED SCREW OF 3.5 MM X 20 MM, BUT AGAIN A SCREW LOCKED OF 3.5 MM X 20 MM IN STEEL WAS PLACED DUE TO THE MISSING TITANIUM SCREW OF 3.5 MM X 20 MM LENGTH IN THE TITANIUM SCREW RACK. FIXATION OF THE FIBULA WAS PERFORMED WITHOUT PROBLEMS. BECAUSE OF THIS EVENT, THE DOCTOR WAS UPSET AND MADE THE OBSERVATION OF THE CONFLICT OF MATERIALS THAT CAN PRODUCE METALLOSIS. CONCO

  Patient problems: Foreign Body In Patient

  MAUDE report 7241113 ↗

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,