NA 02.210.120Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982052971), received between Jan 19, 2018 and May 18, 2021 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K071184, K100776, K102694, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 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 SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 20 MM. THIS REPORT IS 10 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842187 ↗
• InjuryMay 18, 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 SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 20 MM. THIS REPORT IS 9 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842185 ↗
• InjuryMay 18, 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 SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 20MM. THIS REPORT IS 5 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842165 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) VARIABLE LOCKING COMPRESSION PLATE, TWO (2) CORTEX SCREWS, AND FIVE (5) LOCKING SCREWS ON UNKNOWN DATE. THE SURGEON REMOVED THE PLATE AND SCREWS SUCCESSFULLY AND NOTHING WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT (PART # 02.111.720, LOT # UNKNOWN, QUANTITY 1); 2.4MM VA LOCKING SCREW STARDRIVE 20MM (PART # 02.210.120, LOT # UNKNOWN, QUANTITY 4); 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 202.876; LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 20MM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10667160 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) VARIABLE LOCKING COMPRESSION PLATE, TWO (2) CORTEX SCREWS, AND FIVE (5) LOCKING SCREWS ON UNKNOWN DATE. THE SURGEON REMOVED THE PLATE AND SCREWS SUCCESSFULLY AND NOTHING WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT (PART # 02.111.720, LOT # UNKNOWN, QUANTITY 1); 2.4MM VA LOCKING SCREW STARDRIVE 20MM (PART # 02.210.120, LOT # UNKNOWN, QUANTITY 4); 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 202.876; LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 20MM. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10667157 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON SEPTEMBER 21, 2020, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) VARIABLE LOCKING COMPRESSION PLATE, TWO (2) CORTEX SCREWS, AND FIVE (5) LOCKING SCREWS ON UNKNOWN DATE. THE SURGEON REMOVED THE PLATE AND SCREWS SUCCESSFULLY AND NOTHING WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.4 MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT (PART # 02.111.720, LOT # UNKNOWN, QUANTITY 1); 2.4 MM VA LOCKING SCREW STARDRIVE 20 MM (PART # 02.210.120, LOT # UNKNOWN, QUANTITY 4); 2.7 MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16 MM (PART # 202.876; LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 2.4 MM VA LOCKING SCREW STARDRIVE 20 MM. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10667135 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON SEPTEMBER 21, 2020, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) VARIABLE LOCKING COMPRESSION PLATE, TWO (2) CORTEX SCREWS, AND FIVE (5) LOCKING SCREWS ON UNKNOWN DATE. THE SURGEON REMOVED THE PLATE AND SCREWS SUCCESSFULLY AND NOTHING WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT (PART # 02.111.720, LOT # UNKNOWN, QUANTITY 1); 2.4MM VA LOCKING SCREW STARDRIVE 20MM (PART # 02.210.120, LOT # UNKNOWN, QUANTITY 4); 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 202.876; LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 20MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10667128 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) VARIABLE LOCKING COMPRESSION PLATE, TWO (2) CORTEX SCREWS, AND FIVE (5) LOCKING SCREWS ON UNKNOWN DATE. THE SURGEON REMOVED THE PLATE AND SCREWS SUCCESSFULLY AND NOTHING WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT (PART # 02.111.720, LOT # UNKNOWN, QUANTITY 1); 2.4MM VA LOCKING SCREW STARDRIVE 20MM (PART # 02.210.120, LOT # UNKNOWN, QUANTITY 4); 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 202.876; LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 20MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10667115 ↗
• InjuryMar 19, 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 HAD A CONTACT DERMATITIS DUE TO AN ALLERGIC REACTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEM ON AN UNKNOWN DATE. THE PATIENT IS NOW TAKING STEROIDS FOR CONTACT DERMATITIS AND DOES NOT REQUIRE REVISION SURGERY. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS IS 4 OF 5 FOR REPORT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9856827 ↗
• MalfunctionMay 24, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON RECEIVING DELIVERY ON AN UNKNOWN DATE, TWO (2) DRILL BIT WITH DEPTH MARK QUICK COUPLING AND SIX (6) VARIABLE ANGLE LOCKING SCREW WITH STARDRIVE RECESS PACKAGE ARRIVED EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.4MM VA LOCKING SCREW STARDRIVE 20MM. THIS IS REPORT 6 OF 8 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8642055 ↗
• MalfunctionMar 28, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW WENT THROUGH THE PLATE INTO THE PATIENTS BONE AND THE VARIABLE ANGLE TABS IN THE PLATE BROKE WHILE INSERTING THE SCREW DURING A LEFT DISTAL RADIUS PROCEDURE ON (B)(6) 2018. THE BROKEN FRAGMENTS WERE REMOVED EASILY WITHOUT ANY DIFFICULTY. THE PLATE AND SCREW WERE REMOVED AND A NEW PLATE WAS INSERTED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF ABOUT 10 MINUTES. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7379977 ↗
• MalfunctionMar 21, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, A VARIABLE ANGLE 2.4MM LOCKING SCREW WOULD NOT LOCK INTO A DISTAL HOLE ON THE RADIAL SIDE OF THE VOLAR TWO COLUMN DISTAL RADIUS PLATE. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER VARIABLE ANGLE LOCKING SCREW WHICH THEN LOCKED INTO THE PLATE. THIS CAUSED AN APPROXIMATE TWO (2) MINUTE DELAY, HOWEVER, THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. NO ADDITIONAL X-RAYS WERE TAKEN. CONCOMITANT PART: VOLAR TWO COLUMN DISTAL RADIUS PLATE (PART: 02.111.631, LOT NUMBER UNKNOWN, QUANTITY ONE). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359418 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, WHO WAS IMPLANTED WITH A SYNTHES DISTAL RADIUS PLATE AND SCREWS ON (B)(6) 2017, EXPERIENCED AN INFECTION AT THE IMPLANT SITE. THE PATIENT WAS REVISED ON (B)(6) 2017, WHEN THE PLATE WAS LEFT IMPLANTED AND FOUR 2.4MM VARIABLE ANGLE LOCKING SCREWS WERE EXPLANTED. FOUR OF THE SCREWS WERE REPLACED WITH THREE NEW SCREWS (12MM, 16MM AND 20MM LENGTHS X1 EACH). THE PATIENT'S WOUND WAS CLEANED OUT AND THE SURGEON RE-POSITIONED AND REPLACED THE SCREWS TO GET THE BETTER PURCHASE OF THE PATIENT BONE. ONE OF THE SCREWS WAS NOT REPLACED. THE SURGEON FELT THAT MAKING THE CONSTRUCT MORE STABLE WOULD BE MORE BENEFICIAL FOR THE PATIENT THAN JUST CLEANING THE WOUND ALONE. THERE WERE NO REPORTS THAT THE DEVICE HAD LOOSENED, MIGRATED, BACKED-OUT OR MALFUNCTIONED. THE PATIENT WAS REPORTED TO BE ON STEROIDS AND BE SUBSEQUENTLY IMMUNOCOMPROMISED. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. IT IS UNKNOWN IF THE INFECTION HAS SUBSIDED. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 20MM THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7205659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, K100776, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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
• Z-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor