NA 02.127.170Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982043368), received between Jan 17, 2019 and Apr 27, 2023 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2022 TO IMPLANT THE DEVICE. ON (B)(6) 2023, IT APPEARED THAT THE PATIENT HAD DEVELOPED A REACTION ISSUE WITH THE TITANIUM IN HIS LOWER LEG. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 11 FOR (B)(4). THIS REPORT INVOLVES ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/70.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16824207 ↗
• MalfunctionNov 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON INSERTING THE 3.5MM VA LOCKING SCREW, THE SCREW PASSED THROUGH THE LOCKING HOLE OF THE PLATE AND AS THE SURGEON ADVANCED THE LOCKING SCREW, THE HEAD OF THE LOCKING SCREW PASSED CLEAR THROUGH THE LOCKING HOLE OF THE PLATE. THE SURGEON THEN ATTEMPTED TO REMOVE THE SCREW AND AFTER A FEW DIFFERENT METHODS, WAS ABLE TO REMOVE THE SCREW FROM UNDERNEATH THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. THIS REPORT INVOLVES ONE 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/70MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826099 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) OF 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/70. THIS IS REPORT 2 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12796593 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN OPENING WEDGE TIBIA OSTEOTOMY PROCEDURE TO CORRECT A VALGUS DEFORMITY ASSOCIATED WITH A PREVIOUS MVA. THE PATIENT HAD AN UNKNOWN PLATE AND SCREWS ON THE POSTERIOR MEDIAL ASPECT OF THE PROXIMAL TIBIA. TO PERFORM THE OSTEOTOMY PROCEDURE, THE SURGEON REMOVED TWO 3.5MM LOCKING SCREWS FROM THE POSTEROMEDIAL PLATE. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT OUTCOME. CONCOMITANT DEVICE REPORTED: UNK - PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM VARIABLE ANGLE LOCKING. THIS REPORT IS 2 OF 2 FOR (B)(4).

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

  MAUDE report 12228035 ↗
• MalfunctionApr 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE 3.5 VA LOCKING SCREW DID NOT LOCK THE UNKNOWN PLATE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN VARIABLE ANGLE PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 3.5 VA LCK SCRW/SLF-TP/STRD/70. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638176 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SCREW REMOVAL DUE TO PAIN. THERE WERE THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS THAT WERE REMOVED. THE IMPLANTED SCREWS WERE TOO LONG, WHICH CAUSED PAIN TO THE PATIENT. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 3.5MM VARIABLE ANGLE LOCKING SCREW/ SLF-TPNG/ STRDRV/ 60MM (PART NUMBER 02.127.160, LOT UNKNOWN, QUANTITY 1), 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/ STRDRV/7 5MM (PART NUMBER 02.127.175, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 3.5MM VARIABLE ANGLE LOCKING SCREW/ SLF-TPNG/ STRDRV/ 70MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10128115 ↗
• MalfunctionNov 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA FOR THE DEFORMITY CORRECTION, A 70MM VARIABLE ANGLE (VA) LOCKING SCREW WENT THROUGH THE PROXIMAL POSTERIOR LOCKING HOLE. IT SUNK INTO THE HOLE SLIGHTLY PAST THE THREADED HOLES, BUT THE SCREW WAS RETAINED. A NEW LOCKING SCREW 70MM WAS USED WITHOUT ANY ISSUES. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: 3.5MM VA-LCP PROXIMAL TIBIAL PLATE (PART # 02.127.320, LOT # 3L92975, QUANTITY 1). UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 5). THIS REPORT IS FOR 1 3.5MM VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371503 ↗
• InjuryJan 17, 2019Adverse 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 HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 9 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258709 ↗
• InjuryJan 17, 2019Adverse 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 HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 3 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258707 ↗
• InjuryJan 17, 2019Adverse 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 HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 7 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258704 ↗
• InjuryJan 17, 2019Adverse 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 HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 8 OF 11 FOR COMPLAINT (B)(4)

  Patient problems: Unspecified Infection

  MAUDE report 8258697 ↗