NA 03.613.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034714578), received between Feb 22, 2017 and May 9, 2024 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOTICED BROKEN PRE-OPERATIVELY. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19281502 ↗
• MalfunctionSep 1, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM POLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, WHILE SCREWING IN THE SCREW ON THE FEEDER, THE THREAD BROKE AND REMAINED IN THE SCREW. THIS REPORT IS FOR AN INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341072 ↗
• MalfunctionSep 16, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE INNER SHAFT FOR EXTRACTION SCREWDRIVER STYLET BECAME CROSS THREADED MAKING THE TOOL NOT USABLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481688 ↗
• MalfunctionAug 17, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE INNER SHAFT FOR EXTRACTION SCREWDRIVER THREADED PORTION SNAPPED OFF THE INNER SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330246 ↗
• MalfunctionSep 17, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DEVICES BROKE. THE END OF THE SCREWDRIVER GOT STUCK IN THE HEAD OF THE SCREW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079361 ↗
• MalfunctionJul 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANTERIOR CERVICAL FUSION, THE TIP OF INNER SHAFT FOR EXTRACTION SCREWDRIVER BROKE OFF INTO THE HEAD OF THE SCREW. THEY WERE ABLE TO GET THE SCREW OUT SO NOTHING WAS LEFT BACK IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DELAY OF 3 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART #: UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776008 ↗
• InjuryJun 5, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING C4-C7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY, THE TIP OF INNER SHAFT FOR EXTRACTION SCREWDRIVER FOR VECTRA REMOVAL DRIVER BROKE OFF INSIDE THE LEFT C6 SCREW WHILE PLACING INTO THE PLATE. THERE WERE FRAGMENTS GENERATED BUT IT WAS NOT REMOVED EASILY. SCREW WAS IMPLANTED INTO PATIENT. ANOTHER SCREWDRIVER WAS USED TO FINISH THE PROCEDURE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: VARIABLE ANGLE CERVICAL SELF-RETAINING SCREW (PART #: 04.613.518, LOT #: UNKNOWN, QUANTITY:1), TITANIUM VECTRA PLATE (PART #:04.613.134, LOT #: UNKNOWN, QUANTITY:1). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8671372 ↗
• InjuryMay 24, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A C3-C6 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF), THE SURGEON BROKE THE INNER SHAFT FOR EXTRACTION SCREWDRIVER INTO THE LEFT C5 18MM UNKNOWN SCREW. THE SURGEON DID NOT FULLY UNSCREW SHAFT FROM SCREW WHILE PULLING UP. THE SMALL TIP OF THE INNER SHAFT WAS THREADED INTO THE SCREW AND WAS NOT POSSIBLE TO REMOVE AND REMAINS IMPLANTED IN THE PATIENT. WITH THE EXCEPTION OF THIS, PROCEDURE WAS PERFORMED SUCCESSFULLY WITH NO OTHER ISSUES. A BACKUP DEVICE WAS AVAILABLE. THERE WAS SURGICAL DELAY OF THREE (3) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8640256 ↗
• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ANTERIOR CERVICAL FUSION, THE TIP OF THE DRIVER BROKE OFF INTO THE UNKNOWN SCREW HEAD. THE UNKNOWN SCREW WAS REMOVED AND REPLACED. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 2 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1).

  Patient problems: Not Applicable

  MAUDE report 8446109 ↗
• InjuryMar 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS PERFORMING C3-C7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). WHILE IMPLANTING A VECTRA SCREW THROUGH A VECTRA PLATE USING THE EXTRACTION SCREWDRIVER, THE TIP OF THE INNER SHAFT OF THE SCREWDRIVER BROKE OFF INTO THE SCREW. THE TIP OF THE DRIVER FRAGMENTS WAS LODGED SOLIDLY INTO THE IMPLANTED SCREW. SURGEON DETERMINED THAT IT WAS NOT GOING ANYWHERE SO HE DETERMINED THERE WAS NO NEED TO REMOVE THE SCREW (WHICH CONTAINED THE FRAGMENT). HE COMPLETED THE PROCEDURE USING A DIFFERENT SCREWDRIVER. THERE WAS NO SURGICAL DELAY OR HARM TO THE PATIENT, AND THERE WAS NO LOOSE FRAGMENT IN THE PATIENT. CONCOMITANT DEVICES REPORTED: CERVICAL SELF-RETAINING SCREWS, SELF-DRILLING (PART 04.613.516, LOT UNKNOWN, QUANTITY 1), TITANIUM VECTRA PLATE (PART 04.613.132, LOT UNKNOWN, QUANTITY 1), EXTRACTION SCREWDRIVER (PART 352.311, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8426006 ↗
• MalfunctionFeb 14, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF AN UNKNOWN PLATE. UPON REMOVAL, TWO (2) SCREW EXTRACTION DRIVERS TIP BROKE OFF. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT CAPTURES THE INTRAOPERATIVE EVENT OF EXTRACTION DRIVERS BREAKAGE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POSTOPERATIVE EVENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340608 ↗
• MalfunctionFeb 14, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF AN UNKNOWN PLATE. UPON REMOVAL, TWO (2) SCREW EXTRACTION DRIVERS TIP BROKE OFF. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT CAPTURES THE INTRAOPERATIVE EVENT OF EXTRACTION DRIVERS BREAKAGE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POSTOPERATIVE EVENT. CONCOMITANT DEVICE: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340605 ↗
• InjuryJan 30, 2019Break; Break

  IT WAS REPORTED THAT AT PLACEMENT AT C5 DURING A C4-7 ANTERIOR CERVICAL DISCECTOMY FUSION SURGERY ON (B)(6) 2019, THE INNER SHAFT OF THE VECTRA REMOVAL DRIVER BROKE OFF INSIDE THE SCREW. THE SURGEON TRIED SEVERAL TIMES TO REMOVE THE SCREW BUT WAS UNSUCCESSFUL. THE SCREW WAS IMPLANTED WITH THE THREADED TIP FRAGMENT STILL INSIDE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF TEN (10) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8290322 ↗
• MalfunctionJan 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON (B)(6) 2019, A PLATE HOLDING DRILL GUIDE BROKE APART WHILE TESTING IT. THE SALES CONSULTANT STATED THAT THERE WAS NOT ANY FORCE APPLIED TO IT. THEY DO NOT KNOW IF IT SUSTAINED A BLOW AND JUST BARELY CLUNG TOGETHER UNTIL THAT MOMENT. THE SALES CONSULTANT SQUEEZED IT WHEN TESTING THE LOCK FUNCTION OF THIS INSTRUMENT. ALSO, IT WAS NOTICED THAT THE THREADS ON THE DISTAL END OF THE INNER SHAFT OF THE SCREW REMOVAL TOOL WERE DAMAGED. THE INNER SHAFT WOULD NOT SCREW INTO A SCREW. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: EXTRACTION SCREWDRIVER (PART # 352.311, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8286369 ↗
• MalfunctionOct 19, 2018Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF UNKNOWN VECTRA SCREWS ON (B)(6) 2018, THE TIPS OF THE INNER SHAFT THAT WERE INSERTED INTO THE EXTRACTION SCREWDRIVER BROKE OFF WHEN THE SURGEON TRIED TO DIRECT THE UNKNOWN VECTRA SCREW AT WHICH POINT INSIDE THE TIP OF THE SCREW HEAD. HOWEVER, THIS HAPPENED TWICE ON THE OTHER SIDE WHERE THE SURGEON TRIED TO REDIRECT ANOTHER UNKNOWN VECTRA SCREW WITH ANOTHER EXTRACTION SCREWDRIVER, THE TIPS OF THE INNER SHAFT INSERTED INTO THE EXTRACTION SCREWDRIVER BROKE OFF INTO A SCREW. SURGEON WAS ABLE TO REMOVE THE UNKNOWN VECTRA SCREWS WITHOUT ANY DELAY TO THE CASE AND USED AN OVERSIZED UNKNOWN SCREWS TO REPLACE THE SCREWS. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE: 4.0MM X 18MM SELF DRILLING VARIABLE ANGLE VECTRA SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2) . EXTRACTION SCREWDRIVER (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2). THIS REPORT IS FOR AN INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985618 ↗
• MalfunctionOct 19, 2018Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF UNKNOWN VECTRA SCREWS ON (B)(6) 2018, THE TIPS OF THE INNER SHAFT THAT WERE INSERTED INTO THE EXTRACTION SCREWDRIVER BROKE OFF WHEN THE SURGEON TRIED TO DIRECT THE UNKNOWN VECTRA SCREW AT WHICH POINT INSIDE THE TIP OF THE SCREW HEAD. HOWEVER, THIS HAPPENED TWICE ON THE OTHER SIDE WHERE THE SURGEON TRIED TO REDIRECT ANOTHER UNKNOWN VECTRA SCREW WITH ANOTHER EXTRACTION SCREWDRIVER, THE TIPS OF THE INNER SHAFT INSERTED INTO THE EXTRACTION SCREWDRIVER BROKE OFF INTO A SCREW. SURGEON WAS ABLE TO REMOVE THE UNKNOWN VECTRA SCREWS WITHOUT ANY DELAY TO THE CASE AND USED AN OVERSIZED UNKNOWN SCREWS TO REPLACE THE SCREWS. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE: 4.0MM X 18MM SELF DRILLING VARIABLE ANGLE VECTRA SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2) , EXTRACTION SCREWDRIVER (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2) . THIS REPORT IS FOR AN INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985536 ↗
• MalfunctionAug 1, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A C4-C7 ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, THE ZERO-P VARIABLE ANGLE (VA) IMPLANT 8MM HEIGHT CONVEX-STERILE WAS INSERTED AT THE C4-C5 LEVEL. UPON INSERTION WITH THE INSERTION DEVICE, THE PLATE DISENGAGED FROM THE PEEK SPACER. THE SURGEON WAS UNABLE TO COMPLETELY RE-ENGAGE THE PLATE TO THE IMPLANT AFTER NUMEROUS ATTEMPTS. A NEW ZERO-P VA IMPLANT WAS REQUESTED AS THE SURGEON WAS UNCOMFORTABLE WITH TRYING TO FORCE THE IMPLANT ON. UPON REMOVING THE ZERO-P VA IMPLANT FROM THE STERILE FIELD, THE SALES CONSULTANT WAS ABLE TO DISENGAGE THE IMPLANT COMPLETELY WITH CONSIDERABLE FORCE. THE PLATE SEEMED TO BE STUCK HALFWAY DOWN THE TRACK ON THE PEEK SPACER. A NEW ZERO-P VA OF THE SAME SIZE WAS IMPLANTED WITH NO ISSUES. THE INNER SHAFT FOR EXTRACTION SCREWDRIVER WAS REPORTEDLY BROKEN, AND THE FRAGMENT IS STILL LOCATED INSIDE OF A TITANIUM CERVICAL SELF RETAINING SCREW THAT WAS NOT IMPLANTED INTO THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE/S REPORTED: INSERTION DEVICE (PART# 03.647.963,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739980 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED THAT FOR AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE SURGICAL TEAM WAS PULLING INSTRUMENTS AND WHEN THEY PUT THE INNER SHAFT INTO THE REMOVAL DRIVER THEY NOTICED THE TIP OF THE REMOVAL DRIVER WAS MISSING AS IF IT HAD BEEN BROKEN OFF (OF THE INNER SHAFT). THEN DURING THE PROCEDURE, THEY NOTICED THE THAT TIP OF THE AWL WAS SLIGHTLY BENT AND VERY WORN. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR AN INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703657 ↗
• MalfunctionMar 30, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY PERFORMED ON AN UNKNOWN DATE, THE INNER SHAFT FOR EXTRACTION SCREWDRIVER BROKE. THE BROKEN FRAGMENT WAS RETRIEVED EASILY AND WAS NOT LEFT IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385101 ↗
• MalfunctionMar 15, 2018Break; Break

  IT WAS REPORTED THAT THE THREADED TIP WAS FOUND BROKEN OFF THE INNER SHAFT OF THE VECTRA REMOVAL DRIVER. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A DRIVER. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7342972 ↗
• InjuryMar 8, 2018Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION, THE SURGEON WAS INSERTING A 4.0MM X 16MM VARIABLE ANGLE SCREW USING THE REMOVAL DRIVER, THE TIP OF THE INNER SHAFT BROKE OFF INTO THE SCREW HEAD DURING AN ANTERIOR CERVICAL FUSION. THE SURGEON GOT THE SCREW (WITH INNER SHAFT TIP BROKEN OFF INSIDE THE HEAD) OUT OF THE PATIENT/PLATE. THE SURGEON THEN REPLACED IT WITH A LARGER DIAMETER RESCUE SCREW (4.5MM X 16MM VARIABLE ANGLE SCREW). THERE WAS NO REPORTED SURGICAL DELAY. THE BROKEN TIP WAS RETAINED IN THE SCREW AND RETRIEVED. THE ENTIRE SCREW WAS INTACT - NO BREAKAGE OF THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: 4.0MM TITANIUM CERVICAL SELF-RETAINING SCREW, SELF-DRILLING/VARIABLE ANGLE 16MM (PART # 04.613.516, LOT # UNKNOWN, QUANTITY OF 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4)

  Patient problems: No Code Available

  MAUDE report 7326087 ↗
• MalfunctionDec 29, 2017Break; Break

  WHILE PERFORMING AN INITIAL ANTERIOR CERVICAL DISC FUSION AT LEVELS C4-C6, ON (B)(6) 2017, THE SURGEON WAS TIGHTENING A SCREW IN THE VECTRA PLATE SYSTEM WHEN THE SCREWDRIVER TIP BROKE OFF. THE FRAGMENT WAS RETRIEVED QUICKLY, AND ANOTHER SCREW DRIVER WAS USED TO FINISH THE CASE. THERE WAS NO DELAY OR HARM TO THE PATIENT. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155019 ↗
• MalfunctionFeb 22, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE INNER SHAFT BROKE OVER THE YEARS. THIS HAPPEN DURING SURGERY WITH NO DELAY TO SURGERY TIME. IT BROKE BEFORE THE SCREW WAS INSERTED IN THE PATIENT. PROCEDURE SUCCESSFULLY COMPLETED. FINISHED WITH ANOTHER INSTRUMENT. NO PATIENT HARM WAS REPORTED. THIS COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349984 ↗