VECTRA 04.613.136Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034737164), received between May 4, 2018 and Aug 4, 2020 — classified as 1 injury, 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K050451); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS PUTTING A VECTRA PLATE IN A PATIENT, AND FIVE (5) OF SIX (6) UNKNOWN SCREWS WERE PUT IN. THE SURGEON WENT TO INSERT THE LAST UNKNOWN 4X16 MM SCREW, HOWEVER, THE UNKNOWN 4X16MM SCREW WOULD NOT LOCK. THE SURGEON TRIED DRILLING AGAIN AND PUTTING A SMALLER UNKNOWN 4X14MM SCREW IN AND THE PLATE DID NOT LOCK. THE SURGEON TRIED A RESCUE UNKNOWN 4.5X16MM SCREW, THE PLATE STILL DID NOT LOCK AND THE SURGEON DETERMINED THAT AT THIS TIME THE LOCKING MECHANISM WAS STUCK IN THE OPEN POSITION. SO THE SURGEON DECIDED TO REMOVE THE PLATE AND TRY ANOTHER. AS THE SURGEON WAS REMOVING THE UNKNOWN SCREWS USING AN UNKNOWN REMOVAL DRIVER DIRECTLY NEXT TO THE ONE MALFUNCTIONING, THE LOCKING MECHANISM BROKE ON THE ONE HE WAS REMOVING. ALL THE REST OF THE SCREWS WERE REMOVED WITHOUT A PROBLEM. ANOTHER UNKNOWN 36MM PLATE WAS THEN PUT IN. ALL SCREWS IN THE NEW PLATE WENT IN FINE AND LOCKED CORRECTLY WITHOUT A PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCRE

  Patient problems: Injury; No Code Available

  MAUDE report 10365598 ↗
• MalfunctionMay 4, 2018Bent; Bent

  IT WAS REPORTED THAT ONE OF THE RETAINING CLIPS ON A 36MM SYNTHES VECTRA PLATE WAS FOUND TO BE DEFECTIVE AFTER IMPLANTATION. THE CLIP WAS REPORTED TO NOT MOVE TO THE SIDE, CAUSING THE PLATE TO BE UNABLE TO HOLD THE SCREWS PROPERLY. FOLLOWING THE DISCOVERY, THE SURGEON REPLACED THE 36MM SYNTHES VECTRA PLATE WITH ANOTHER 36MM SYNTHES VECTRA PLATE. THE SAME FIVE SCREWS USED TO IMPLANT THE ORIGINAL PLATE WERE USED TO IMPLANT THE NEW PLATE. THIS EXCHANGE OF PLATES CAUSED AN ESTIMATED 5 MINUTE DELAY IN THE SURGERY, WITH NO OTHER IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. REPORTED CONCOMITANT DEVICES: UNKNOWN SCREWS: TRAUMA (UNKNOWN PART NUMBERS, UNKNOWN LOT NUMBERS, QUANTITY 5). THIS REPORT IS FOR A TI VECTRA(TM) PLATE 2 LEVEL/36MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7488356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050451. One submission often covers many models, so check the product and lot details in each record.

• Z-2674-2014 · Sep 2, 2014 · Terminated
  DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4
• Z-0782-2013 · Aug 6, 2012 · Terminated
  Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-
• Z-0781-2013 · Aug 6, 2012 · Terminated
  Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Sy