NA 04.617.814Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034742274), received between Mar 9, 2018 and Jul 15, 2022 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K072981, K152239); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, 1 OF THE 4 ZERO-P SCREWS WAS REMOVED BECAUSE THE SCREW WAS LOOSE AND REMOVING FROM THE IMPLANT. THE IMPLANT WAS INSERTED ON (B)(6) 2021. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2022. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.0MM TI CERV SPINE LKNG SCR 14MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 15026448 ↗
• InjuryMar 9, 2022Mechanical Problem; Activation, Positioning or Separation Problem; Compatibility Problem; Mechanical Problem; Activation, Positioning or Separation Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION FOR UNKNOWN REASON. WHEN INSERTING A ZERO P SCREW, THE SCREW FELL OFF THE DRIVER AND INTO THE SURGICAL SITE. WHILE TRYING TO RETRIEVE, THE SCREW WAS INADVERTENTLY PUSHED DEEPER IN THE SURGICAL SITE. ALTHOUGH THE SCREW COULD BE VISUALIZED ON X-RAY, THE SURGEON WAS UNABLE TO RETRIEVE THE SCREW AFTER MANY ATTEMPTS. IT WAS DETERMINED TO LEAVE THE SCREW LOOSE IN THE WOULD AS A FOREIGN BODY AS THERE WAS A GREATER RISK OF INJURY WITH FURTHER DISSECTION. SURGEON IS AWARE THAT THE IMPLANT IS MADE FROM TITANIUM BUT WOULD LIKE TO KNOW IF THERE IS ANY CONCERN OF THE SCREW MIGRATING WITH AN MRI. EXPLORATORY ACTIONS WERE TAKEN TO RETRIEVE SCREW. FLUOROSCOPY WAS USED TO LOCATE SCREW BUT LOCATION PROVED DIFFICULT TO ACCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 15 MINUTES. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE 3.0MM TI CERV SPINE LKNG SCR 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13711663 ↗
• InjuryMar 8, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON NEEDED TO DO A REVISION OF A C3-5 ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO A C5 NERVE PALSY THAT THE PATIENT PRESENTED WITH POST OP FROM HIS ORIGINAL SURGERY FOUR WEEKS PRIOR. THE ORIGINAL SURGERY WAS COMPLETED AT (B)(6) HOSPITAL ON (B)(6) 2021. THE PATIENT SUFFERED A FALL IN THE BATHTUB AND UPON FURTHER CT DIAGNOSTIC IMAGING, IT APPEARED THAT THE SCREWS FROM THE ZERO-P NATURAL PLATE PULLED OUT OF C4 AND WERE FLOATING ANTERIOR TO AN ADJACENT VECTRA PLATE. THE SURGEON REMOVED THE FLOATING SCREWS AND ALL EXISTING HARDWARE TO ASSESS THE C5 NERVE PALSY THEN RE-INSTRUMENTED FROM C3-5 WITH NEW HARDWARE. THE SCREWS FROM THE ZERO-P NATURAL PLATE LOOSENED FROM THE PLATE POSTOPERATIVELY. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11437310 ↗
• InjuryMar 8, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON NEEDED TO DO A REVISION OF A C3-5 ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO A C5 NERVE PALSY THAT THE PATIENT PRESENTED WITH POST OP FROM HIS ORIGINAL SURGERY FOUR WEEKS PRIOR. THE ORIGINAL SURGERY WAS COMPLETED AT (B)(6) ON (B)(6) 2021. THE PATIENT SUFFERED A FALL IN THE BATHTUB AND UPON FURTHER CT DIAGNOSTIC IMAGING, IT APPEARED THAT THE SCREWS FROM THE ZERO-P NATURAL PLATE PULLED OUT OF C4 AND WERE FLOATING ANTERIOR TO AN ADJACENT VECTRA PLATE. THE SURGEON REMOVED THE FLOATING SCREWS AND ALL EXISTING HARDWARE TO ASSESS THE C5 NERVE PALSY THEN RE-INSTRUMENTED FROM C3-5 WITH NEW HARDWARE. THE SCREWS FROM THE ZERO-P NATURAL PLATE LOOSENED FROM THE PLATE POSTOPERATIVELY. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11437249 ↗
• InjurySep 20, 2019Device Slipped; Material Twisted/Bent; Migration; Device Slipped; Material Twisted/Bent; Migration

  IT WAS REPORTED THAT THE PATIENT HAD AN ANTERIOR CERVICAL DISCECTOMY & FUSION IMPLANTATION ON (B)(6) 2019. DURING A FOLLOW UP ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A CERVICAL SPINE LOCKING SCREW WHICH WAS FOUND TO BE BACKING OUT DUE TO LOOSENING. NO SURGICAL DELAY AND ADVERSE EVENTS WERE REPORTED. LOOSENED SCREW WAS REMOVED, THE REST OF THE ZERO-P DEVICE REMAINED INTACT, AND FUSION WAS TAKING PLACE. CONCOMITANT DEVICE REPORTED: UNK - CAGE / PLATE: ZERO-P (PART / LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.0 MM TI CERVICAL SPINE LOCKING SCREW 14 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9098416 ↗
• InjuryMay 15, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL BECAUSE THE PATIENT COMPLAINED OF PAIN AND DYSPHASIA AND THE CERVICAL SPINE LOCKING SCREW BACKED OUT OF A ZERO PROFILE CONSTRUCT AT C4/5 LEVEL. THE SURGEON MADE AN INCISION AND PULLED OUT THE SCREW SUCCESSFULLY WITH A PICKUP. AFTER CLOSING THE INCISION, THE PATIENT WAS REPOSITIONED AND FUSED WITH C3-C7 WITH GLOBUS. DATE OF THE ORIGINAL IMPLANT WAS ON (B)(6) 2015. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: 3.0 TI CERVICAL SPINE LOCKING SCREW 14MM (PART 04.617.814, LOT UNKNOWN, QUANTITY 3), ZERO PROFILE LORDOTIC IMPLANT STERILE (PART 04.617.127S, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A CERVICAL SPINE LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 8611858 ↗
• MalfunctionMar 9, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, THREE (3) SEPARATE 3.0MM CERVICAL SPINE LOCKING SCREWS CHIPPED DURING THE TORQUEING STAGE. NO FRAGMENTS WERE GENERATED. THE SCREWS WERE REPLACED WITH NEW SCREWS, SURGERY WAS COMPLETED WITH NO FURTHER ISSUES. THIS REPORT IS FOR ONE (1) 3.0MM CERVICAL SPINE LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329132 ↗
• MalfunctionMar 9, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, THREE (3) SEPARATE 3.0MM CERVICAL SPINE LOCKING SCREWS CHIPPED DURING THE TORQUING STAGE. NO FRAGMENTS WERE GENERATED. THE SCREWS WERE REPLACED WITH NEW SCREWS, SURGERY WAS COMPLETED WITH NO FURTHER ISSUES. THIS REPORT IS FOR ONE (1) 3.0MM CERVICAL SPINE LOCKING SCREW. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329124 ↗
• MalfunctionMar 9, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, THREE (3) SEPARATE 3.0MM CERVICAL SPINE LOCKING SCREWS CHIPPED DURING THE TORQUEING STAGE. NO FRAGMENTS WERE GENERATED. THE SCREWS WERE REPLACED WITH NEW SCREWS, SURGERY WAS COMPLETED WITH NO FURTHER ISSUES. THIS REPORT IS FOR ONE (1) 3.0MM CERVICAL SPINE LOCKING SCREW. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329108 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072981, K152239. One submission often covers many models, so check the product and lot details in each record.

• Z-0104-2012 · Sep 23, 2011 · Terminated
  Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.
• Z-1348-2009 · Feb 10, 2009 · Terminated
  Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.