NA 04.211.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886982119025), received between May 16, 2018 and Sep 17, 2024 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

7 other recalls cover devices cleared under the same FDA submission (K100776, K103243); 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORFI WITH THE VA LOCKING SCREW FOR THE CLAVICLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE LOCKING SCREWS IN QUESTION BROKE OFF UNDER THE SCREW HEADS. ALTHOUGH THE SCREW HEADS AND THE PLATE WERE REMOVED, THE SCREW SHAFTS REMAINED IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20241350 ↗
• InjurySep 17, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORFI WITH THE VA LOCKING SCREW FOR THE CLAVICLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE LOCKING SCREWS IN QUESTION BROKE OFF UNDER THE SCREW HEADS. ALTHOUGH THE SCREW HEADS AND THE PLATE WERE REMOVED, THE SCREW SHAFTS REMAINED IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20241299 ↗
• InjurySep 17, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORFI WITH THE VA LOCKING SCREW FOR THE CLAVICLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE LOCKING SCREWS IN QUESTION BROKE OFF UNDER THE SCREW HEADS. ALTHOUGH THE SCREW HEADS AND THE PLATE WERE REMOVED, THE SCREW SHAFTS REMAINED IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM, THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20241206 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO TREAT THE DISTAL CLAVICLE WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VALCP)AND THE SCREWS; LATERAL MIDDLE CS2 LEFT. AFTER THE SURGERY, ON (B)(6) 2024, THE THREE (3) DISTAL SCREWS WERE FOUND TO BE BROKEN. THE BREAKAGE WAS FOUND AFTER REHABILITATION. THE PLAN IS NOT TO PERFORM A REVISION SURGERY, BUT TO MONITOR THE PROGRESS AND TRY TO ACHIEVE BONE FUSION. THE PATIENT STATUS/OUTCOME IS REPORTED AS STABLE. THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468968 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO TREAT THE DISTAL CLAVICLE WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VALCP)AND THE SCREWS; LATERAL MIDDLE CS2 LEFT. AFTER THE SURGERY, ON (B)(6) 2024, THE THREE (3) DISTAL SCREWS WERE FOUND TO BE BROKEN. THE BREAKAGE WAS FOUND AFTER REHABILITATION. THE PLAN IS NOT TO PERFORM A REVISION SURGERY, BUT TO MONITOR THE PROGRESS AND TRY TO ACHIEVE BONE FUSION. THE PATIENT STATUS/OUTCOME IS REPORTED AS STABLE. THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468905 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO TREAT THE DISTAL CLAVICLE WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VALCP)AND THE SCREWS; LATERAL MIDDLE CS2 LEFT. AFTER THE SURGERY, ON (B)(6) 2024, THE THREE (3) DISTAL SCREWS WERE FOUND TO BE BROKEN. THE BREAKAGE WAS FOUND AFTER REHABILITATION. THE PLAN IS NOT TO PERFORM A REVISION SURGERY, BUT TO MONITOR THE PROGRESS AND TRY TO ACHIEVE BONE FUSION. THE PATIENT STATUS/OUTCOME IS REPORTED AS STABLE. THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468739 ↗
• MalfunctionMar 25, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT UNKNOWN SURGERY. A LOCKING SCREW WAS TRIED TO BE USED FOR PLACEMENT OF A PLATE, BUT TO START OVER TO PLACE THE PLATE, THE PLATE WAS TAKEN OUT ONCE, AND THE LOCKING SCREW WAS TRIED TO BE USED AGAIN. A TORQUE SCREWDRIVER WAS BEING USED, MEANWHILE IT DOUBLED DOWN ON TIGHTENING LEADING THE LOCKING SCREW HEAD PORTION BROKE OFF AND CAME OFF. A REMAINED SHAFT PORTION WAS REMOVED BY A FORCEPS, ACCORDINGLY THERE IS NO ANY FRACTIONS IN PATIENT¿S BODY. THE SURGEON CONFIRMED BY X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L20 TA THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18967548 ↗
• InjuryJul 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR A DISTAL CLAVICLE FRACTURE. AFTER SURGERY, ON (B)(6) 2023, THE THREE SCREWS INSERTED AT THE DISTAL HOLES OF THE PLATE WERE FOUND TO BE BROKEN. REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. BONE UNION WAS ACHIEVED, SO THE PLATE AND SCREWS WILL BE REMOVED. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17332801 ↗
• InjuryMay 12, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A SURGERY TREATING HALLUX VALGUS OF RIGHT FOOT FIRST METATARSAL WITH A VA-X PLATE AND FOUR 2.7MM VA LOCKING SCREWS THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, FOLLOW-UP OBSERVATION SHOWED A TENDENCY TOWARD NON-UNION, AND FRACTURE OF THE SCREW WAS ALSO FOUND. ON (B)(6) 2023, A REVISION SURGERY WILL BE PERFORMED. IN THE REVISION SURGERY, THE BROKEN SCREW WILL BE REMOVED. REGARDING THE BREAKAGE OF THE SCREW, THE SURGEON COMMENTED THAT IT MIGHT BE CAUSED BY NON-UNION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16924453 ↗
• MalfunctionMay 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY WITH VA-CLAVICLE PLATE AND VA LOCKING SCREW. DURING INSERTION OF THE MEDIAL SCREW OF THE VA-CLAVICLE PLATE, AN EVENT OCCURRED IN WHICH THE SCREW WAS DIFFICULT TO INSERT, PARTLY BECAUSE THE PATIENT HAD GOOD BONE QUALITY. AFTER 2.0 MM DRILLING, THE DIRECTION OF THE SCREW WAS CHECKED BY DEPTH GAUGE AND INSERTION WAS ATTEMPTED, BUT THE SCREW COULD NOT BE INSERTED AT ALL. THE SURGEON SLIGHTLY WIDENED THE INSERTION OPENING WITH A HOSPITAL-OWNED 2.4 MM K-WIRE AND REINSERTED THE SCREW, WHICH INSERTED SMOOTHLY. AFTER THE SURGERY, THE SURGEON REQUESTED THAT A TAPPING SCREW BE NEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - DEPTH GAUGES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNK - GUIDE/COMPRESSION/K-WIRES: TRAUMA(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNK - PLATES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN THIS IS REPORT 1 OF 4 FOR COMPLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883749 ↗
• MalfunctionJan 9, 2023Break; Migration; Break; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR CLAVICULAR DIAPHYSIS WITH THE PRODUCTS IN QUESTION. TWO MONTHS LATER, ON (B)(6) 2022 SCREW BREAKAGE AND BACKOUT WAS DISCOVERED. AS OF (B)(6) 2022, THE OUTSIDE IS INTACT, AND THE PATIENT IS BEING MONITORED FOR BONE FUSION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121285 ↗
• InjuryOct 3, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL CLAVICLE WITH 5 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON AUGUST 22, IT WAS CONFIRMED THAT 5 DISTAL SCREWS WERE BROKEN. IT IS UNKNOWN WHEN THE SCREWS BROKE. THE SURGEON COMMENTED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD DEMENTIA. CONCOMITANT DEVICE REPORTED: 2.7 TI VA LCP CLAV PL LAT/ CS1/ LFT/ -S (04.112.610S, 640P853) THIS IS REPORT 9 OF 9 FOR (B)(4). THIS REPORT IS 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM

  Patient problems: Failure of Implant

  MAUDE report 15533464 ↗
• InjuryOct 3, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL CLAVICLE WITH 5 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6), IT WAS CONFIRMED THAT 5 DISTAL SCREWS WERE BROKEN. IT IS UNKNOWN WHEN THE SCREWS BROKE. THE SURGEON COMMENTED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD DEMENTIA. CONCOMITANT DEVICE REPORTED: 2.7 TI VA LCP CLAV PL LAT/ CS1/ LFT/ -S (04.112.610S, 640P853). THIS IS REPORT 3 OF 9 FOR (B)(4). THIS REPORT IS V2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM.

  Patient problems: Failure of Implant

  MAUDE report 15529576 ↗
• InjuryOct 3, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL CLAVICLE WITH 5 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6), IT WAS CONFIRMED THAT 5 DISTAL SCREWS WERE BROKEN. IT IS UNKNOWN WHEN THE SCREWS BROKE. THE SURGEON COMMENTED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD DEMENTIA. CONCOMITANT DEVICE REPORTED: 2.7 TI VA LCP CLAV PL LAT/ CS1/ LFT/ -S (04.112.610S, 640P853). THIS IS REPORT 2 OF 9 FOR (B)(4). THIS REPORT IS FOR 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM.

  Patient problems: Failure of Implant

  MAUDE report 15529386 ↗
• InjurySep 27, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE OF ELBOW BONE HEAD WITH THE PLATE AND SCREWS IN QUESTION. ON AN UNKNOWN DATE, THE FIXATION WAS LOST. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AND COMPLETED SUCCESSFULLY WITH A NEW PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15490837 ↗
• MalfunctionAug 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN OSTEOSYNTHESIS FOR RIGHT DISTAL HUMERUS FRACTURE, FOUR (4) CONSECUTIVE LOCKING SCREWS FAILED TO LOCK INTO THE FOUR HOLES OF A PLATE. THE SURGEON HAD BEEN FOLLOWING THE SURGICAL TECHNIQUE AND HAD STARTED INSERTING THE LOCKING SCREWS USING A DRILL SLEEVE. THE SURGEON CONSULTED WITH THE SALES REP AND ULTIMATELY DECIDED TO PROCEED USING A NEW PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES OF DELAY. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285846 ↗
• MalfunctionJul 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR CLAVICLE SHAFT FRACTURE. IN THE SURGERY, THE SCREW IN QUESTION WAS BROKEN. THE DISTAL PORTION OF THE PLATE WAS TEMPORARILY FIXED WITH A K-WIRE, AND THE PROXIMAL PORTION WAS FIXED WITH TWO LOCKING SCREWS. THEN, SINCE THE REDUCTION POSITION WAS REQUIRED TO BE CORRECTED, HE ATTEMPTED TO REMOVE THE SECOND SCREW FROM THE PROXIMAL POSITION AND THE SCREW HEAD WAS BROKEN. THE SCREW SHAFT HAS BEEN LEFT BEHIND IN THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY BY FIXING THE OTHER HOLE WITHOUT ANY SURGICAL DELAY. HE COMMENTED THAT HE MIGHT NOT HAVE HANDLED THE DRIVER VERTICALLY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DETAIL: UNK PLATE( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). UNK - SCREWDRIVERS: SHAFTS( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). UNK - CABLE/WIRE( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN, THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15012535 ↗
• InjuryJul 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A POST-OP SCREW BREAKAGE. THE PATIENT WAS TREATED FOR A RADIUS FRACTURE ON (B)(6) 2021, WITH A VA-LCP DISTAL TWO COLLUM PLATE. THE PATIENT SUPPORTED HER ARM ON THE TABLE AND THE PLATE SECONDARILY DISLOCATED DUE TO FOUR SCREWS BREAKING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THIS REPORT INVOLVES (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

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

  MAUDE report 12135460 ↗
• InjuryJul 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A POST-OP SCREW BREAKAGE. THE PATIENT WAS TREATED FOR A RADIUS FRACTURE ON (B)(6) 2021, WITH A VA-LCP DISTAL TWO COLLUM PLATE. THE PATIENT SUPPORTED HER ARM ON THE TABLE AND THE PLATE SECONDARILY DISLOCATED DUE TO FOUR SCREWS BREAKING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THIS REPORT INVOLVES ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

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

  MAUDE report 12135397 ↗
• InjuryMay 16, 2018Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF DISTAL HUMERUS WITH PERPENDICULAR PLATING USING TITANIUM VA ELBOW SYSTEM WITH MEDIAL PLATE AND POSTEROLATERAL PLATE ON (B)(6) 2018. ONE MONTH AFTER SURGERY, X-RAY WAS DONE AND APPEARED TO INDICATE POSSIBILITY THAT ONE OR MORE DISTAL SCREWS OF POSTEROLATERAL PLATE HAD BACKED OUT FROM PLATE ALONG WITH A LOSS OF REDUCTION. ON (B)(6) 2018, REVISION WAS PERFORMED AND REVEALED THAT THE LOCKING SCREW AND METAPHYSEAL SCREW WERE BACKED OUT. UPON SCREW REMOVAL, THE LOCKING SCREW WAS FOUND TO BE BROKEN AT JUNCTION OF HEAD ELEMENT AND SHAFT WITH AN ESTIMATED BROKEN LENGTH OF 20 AS CHECKED BY A SURGICAL TECHNICIAN. OTHER SCREWS REMOVED FROM POSTEROLATERAL PLATE WERE INTACT WITH NO NOTED ABNORMALITIES. POSTEROLATERAL PLATE REMOVED INTACT WITH NO APPARENT ABNORMALITIES NOTED BY CUSTOMER. MEDIAL PLATE AND SCREWS FROM THE IMPLANTATION SURGERY WAS LEFT IN PLACE. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS AN UNKNOWN PATIENT OUTCOME. NO ADDITIONAL INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN MEDIAL PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); UNKNOWN POSTEROLATERAL PLATE(PART# UNKNOWN

  Patient problems: Failure of Implant

  MAUDE report 7518258 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100776, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag