Zero-P VARecalls & reported problems across all models
Synthes GmbH · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 16 models of Zero-P VA by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2018 and Sep 25, 2026 — classified as 3 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Zero-P VA problems
Device problems
- Detachment of Device or Device Component16
- Mechanical Problem7
- Break6
- Material Integrity Problem6
- Compatibility Problem5
- Device-Device Incompatibility3
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient12
- No Code Available4
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
Zero-P VA models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zero-P VA 04.647.127SIntervertebral fusion device with integrated fixation, cervical7 reports
- Zero-P VA 04.647.128SIntervertebral fusion device with integrated fixation, cervical6 reports
- Zero-P VA 04.647.226SIntervertebral fusion device with integrated fixation, cervical5 reports
- Zero-P VA 03.647.963Intervertebral fusion device with integrated fixation, cervical3 reports
- Zero-P VA 04.647.138SIntervertebral fusion device with integrated fixation, cervical3 reports
- Zero-P VA 04.647.227SIntervertebral fusion device with integrated fixation, cervical2 reports
- Zero-P VA 04.647.115SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.126SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.135SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.136SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.137SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.217SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.225SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.228SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.236SIntervertebral fusion device with integrated fixation, cervical1 report
- Zero-P VA 04.647.239SIntervertebral fusion device with integrated fixation, cervical1 report
Recent Zero-P VA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Compatibility Problem
It was reported while the implant was mounted on the implant holder, the holder was squeezed, according to the surgical technique. Then the knurled nut was turned on the thread to fix the position of the holder. Shortly before the nut was at the end position, it stopped turning and was jammed. It could no longer be loosened by hand. It did not come loose even with a clamp or forceps. A new implant had to be unpacked, which was then implanted with a clamp. The surgery could be completed successfully with a ten (10) minute delay and no harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899830 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822347 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
It was reported that Zero-P VA cages and peek cage slid from titanium face upon insertion intraoperatively. There was no patient consequence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822333 ↗MalfunctionApr 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT IMPLANT FELL APART WHEN INSERTING. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818722 ↗MalfunctionMar 17, 2026Material Integrity Problem
IT WAS REPORTED DURING PREPARATION, IT WAS FOUND THAT THE LOCKNUT DOES NOT ROTATE CORRECTLY. THE THREAD APPEARS TO BE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617615 ↗MalfunctionMar 3, 2026Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DURING INSERTION OF ZERO PVA IMPLANTS, PLATE KEPT SEPARATING FROM PEEK PORTION. IMPLANT KEPT DISCONNECTING AND ASKED FOR NEW IMPLANT. SURGERY WAS DELAYED BY 5 MINUTES. NEW CAGE WAS OPENED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495486 ↗MalfunctionJan 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ZERO-P VA CAGE LRG LORDOTIC H7 PEEK AND SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE WERE INVOLVED IN AN INTRAOPERATIVE EVENT DURING A SPINAL FUSION PROCEDURE. DURING INSERTION OF THE INFERIOR SCREW, TWO ARTICULATING DRIVERS BROKE AND THE TITANIUM PORTION OF THE CAGE DETACHED. THE PIN AT THE ARTICULATING JOINT OF THE DRIVERS SHEARED OFF. THE CAGE WAS REMOVED AND REPLACED WITH A NEW ONE, AND A STRAIGHT SHAFT DRIVER WAS USED TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A 10-MINUTE SURGICAL DELAY, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE PATIENT CONSEQUENCES. ALL DEVICE FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990033 ↗MalfunctionDec 26, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED ON (B)(6) 2025 DURING A PROCEDURE THE DEVICE WAS IMPLANTED IN THE PATIENT BUT THE PART CAME OUT AND BROKE INTO HALF. NO PATIENT WAS INJURED AND NO SURGICAL DELAY. PATIENT WAS FITTED ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895563 ↗MalfunctionMay 17, 2024Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT ON (B)(6) 2024, AFTER DRILLING THE SCREW INTO THE SCREW HOLE OF THE CAGE, THE SCREW COULD NOT BE BACKED OUT AGAIN FOR ANGLE CORRECTION BECAUSE THE PLATE ON THE CAGE WAS STUCK. IT WILL NOT UNLOCK. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION. THIS REPORT INVOLVES ONE (1) ZERO-P VA IMPLANT 5MM HEIGHT CONVEX-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19339438 ↗MalfunctionMar 1, 2024Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 09-FEBRUARY-2024, THE ZERO P CAGE IN QUESTION SEPARATED WHEN IT WAS IMPLANTED. IT WAS REMOVED AND ANOTHER ONE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18816195 ↗MalfunctionJan 26, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
MalfunctionNov 1, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
THERE WAS TWO MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18047208 ↗MalfunctionMar 6, 2023Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AN ANTERIOR CERVICAL DISCECTOMY & FUSION CASE WAS BEING PERFORMED WITH THE PRODUCTS IN QUESTION. AFTER A RIGHT SIDED APPROACH AND DISCECTOMY UNDER MICROSCOPE SURGEON INSERTED A (04.647.126) 6MM TRIAL IMPLANT, FROM THE PROJECTED VIEW OF MICROSCOPE IMAGE I SUGGESTED A 7MM OR 8MM TRIAL. THE SURGEON STATED THEY NEVER PUT LARGER THAN A 6MM. THE SURGEON INSPECTED THE IMPLANT BOX AND CONFIRMED THE 6MM SELECTED. THE IMPLANT WAS INSERTED, AND SPACE WAS VISIBLE EITHER SIDE OF THE CAGE. THE SURGEON VOICED CONCERN THAT THE IMPLANT WAS TOO LOOSE I SUGGESTED A LARGER CAGE MAY PROVIDE A MORE EFFECTIVE RESULT. THE SURGEON PROCEEDED TO PREPARE THE CRANIALLY AIMED SCREW AND INSERTED A 14MM SCREW PAST THE LOCKING CLIP, THEN ATTEMPTED TO REPOSITION THE PLATE PORTION OF THE IMPLANT CAUSING IT TO DISCONNECT FROM THE PEEK PORTION ON THE IMPLANT. THE SURGEON THEN BACKED OUT THE INITIAL SCREW AND REMOVED IT SIMULTANEOUSLY ALONG WITH THE PLATE. THE ASSISTANT RETRIEVED THE PEEK PORTION OF THE CAGE WITH BAYONETED FORCEPS. THE SCREW STILL CONNECTED TO THE PLATE WAS LEFT TO BE ADDRESSED LATER AS THE SURGEON STATED IT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16485839 ↗MalfunctionFeb 24, 2023Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ITEM BROKE DURING INSERTION AFTER BEING PACKED WITH BONE. THE PEEK COMPONENT SEPARATED FROM THE GREEN PLATE. THE IMPLANT INSERTER WAS PROPERLY CONNECTED TO THE PLATE AT THE TIME OF INSERTION. THERE WAS A FIVE-MINUTE DELAY RELATED TO THE EVENT. THE SITE USED BACKUP STERILE IMPLANTS TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED, AND THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ZERO-P VA IMPLANT 5MM HEIGHT PARALLEL-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16434902 ↗MalfunctionJan 17, 2023Compatibility Problem; Compatibility Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE DEVICE COULD NOT LOCK. DURING THE SURGERY, IT WAS NOTED THAT THE SPRING COULD NOT BE EJECTED, RESULTING IN LOCKING FAILURE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ZERO-P VA IMPLANT 6MM HEIGHT CONVEX-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16183869 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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