NA 04.614.010Recalls & reported problems
Synthes GmbH · 3.5MM TI CANCELLOUS POLYAXIAL SCREW 10MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034738321), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A SECOND ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE DUE TO CERVICAL STENOSIS WITH RADICULOPATHY, ADJACENT SEGMENT DEGENERATION, OSTEOPOROSIS AND SJOGRENS SYNDROME. THE PATIENT WAS IMPLANTED WITH ONE (1) 4.0MM TITANIUM CANCELLOUS POLYAXIAL SCREW 24MM, TWO (2) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREWS 14MM, ONE (1) 4.0MM TITANIUM CANCELLOUS POLYAXIAL SCREW 26MM, ONE (1) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREW 10MM, FIVE (5) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREWS 12MM , TEN (10) TITANIUM LOCKING SCREWS, TWO (2) TITANIUM CURVED RODS, AND ONE (1) UNKNOWN CONSTRUCTS: SYNAPSE. APPROXIMATELY FIVE (5) DAYS AFTER THE PROCEDURE, THE PATIENT NOTED THAT SHE BEGAN TO HAVE SKIN LESIONS LOCATED ON HER BACK, BILATERAL CLAVICLE REGION, NECK, FACE AND EARS. THE LESIONS WERE DESCRIBED AS LIKE SPIDER BITES THAT WERE TENDER, AND APPEARED AS PAPULES; BUT SHE DID NOT POP, DRAIN OR PICK AT THEM. THEY WOULD RESOLVE ON THEIR OWN; HOWEVER, NEW ONES DEVELOP DAILY. THE PATIENT INDICATED THAT THE SKIN ISSUE HAD BEEN ONGOING AND AFFECTING HER DAILY ACTIVITIES AND HAD BEEN UNDER THE CARE OF A DERMATOLOGIST. AN AQUANIL LOTION WAS USED TO TR
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 8480044 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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