Zero-P VA 04.647.127SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034750736), received between Mar 27, 2018 and Jan 26, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K112068); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18586869 ↗
• MalfunctionNov 2, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2022 WHEN OPENING A ZERO P VA CERVICAL CAGE, THE CAGE HAD THE PEEK SEPARATED FROM THE PLATE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714739 ↗
• MalfunctionSep 28, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, A ZERO-P CA CAGE SEPARATED FROM THE PLATE AND SPACER. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10592746 ↗
• MalfunctionJan 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  02/14/2019: ADDITIONAL INFORMATION RECEIVED FROM SALES CONSULTANT ON FEBRUARY 14, 2019, THE 2 DEVICES THAT WAS RECEIVED, WERE BOTH INVOLVED IN THE INCIDENT. THEY ARE TYPICALLY TOGETHER TO FORM 1 DEVICE. DURING IMPLANTATION, THE DEVICE CAME APART, CAUSING THERE TO BE 2 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262699 ↗
• MalfunctionOct 11, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT THE ZERO PROFILE VARIABLE ANGLE (ZERO-P VA) IMPLANT ON (B)(6) 2018, THE METALLIC PORTION (INTERBODY PLATE) DETACHED FROM THE POLYMER PORTION. ANOTHER IMPLANT WAS AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE NORMALLY WITH A DELAY OF APPROXIMATELY 5 MINUTES. ALL FRAGMENTS WERE RETRIEVED. THIS REPORT IS FOR ONE (1) ZERO-P VA IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958471 ↗
• InjuryAug 21, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2018, THE LATERAL EDGE OF THE ZERO-PROFILE VARIABLE ANGLE (VA) IMPLANT CHIPPED DURING IMPACTION, CAUSING THE FACEPLATE TO DISARTICULATE AND NOT BE ABLE TO RE-ATTACH. THE SURGEON REPLACED THE DEVICE WITH A SHORTER HEIGHT CAGE TO REDUCE THE AMOUNT OF IMPACTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. SURGICAL OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7802081 ↗
• MalfunctionMar 27, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2018, FOR A SPINE FUSION TREATMENT. INTER-OPERATIVE, THE (ZERO-P VA) VARIABLE ANGLE ZERO-PROFILE ANTERIOR CERVICAL INTERBODY FUSION IMPLANT CAME APART UPON INSERTION. UPON INSERTING THE ZERO P VA IMPLANT, THE PEEK AND TITANIUM COMPONENTS SEPARATED UNDER NORMAL INSERTION CONDITIONS. BOTH PIECES WERE EASILY RETRIEVED AND THE SURGEON CHOSE ANOTHER IMPLANT THAT WAS AVAILABLE IN THE OPERATING ROOM. SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS REPORTED IN STABLE CONDITION. THE IMPLANT WILL NOT BE RETURNED. DUE TO THIS ISSUE SURGERY WAS DELAYED. THE REPORTER IS NOT SURE OF THE EXACT AMOUNT OF MINUTES CONCERNING THE DELAY TIME. NO FRAGMENTS WERE GENERATED DURING THE PROCEDURE. NO ADDITIONAL X-RAYS WERE NEEDED. CONCOMITANT DEVICES: INSERTION DEVICE FOR THE ZERO-P VA (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN) UNKNOWN SPINE SCREWS(ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 2 EACH) THIS REPORT IS FOR ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7373945 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112068. One submission often covers many models, so check the product and lot details in each record.

• Z-0455-2014 · Sep 30, 2013 · Terminated
  Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indica