AVS TL 48370124Recalls & reported problems
Stryker Corporation · VERTEBRAL SPACER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613153046462), received between Nov 28, 2016 and Nov 19, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Fracture1
- Loss of or Failure to Bond1
- Material Deformation1
- Material Integrity Problem1
- Mechanical Problem1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN AVS TL VERTEBRAL SPACER FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20719079 ↗MalfunctionJan 9, 2017Loss of or Failure to Bond; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT AN IMPLANT WAS WARPED ON THE AREA WHERE THE INSERTER IS SUPPOSE TO ATTACH TO THE IMPLANT. BECAUSE OF THAT THE IMPLANT WOULDN'T STAY ATTACHED TO THE INSERTER IT KEEP FALLING OFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6234200 ↗InjuryNov 28, 2016Mechanical Problem; Detachment of Device or Device Component; Detachment Of Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT; CAGE BECAME DIS-ATTACHED FROM THE INSERTER DURING IMPLANTATION. WHILE TRYING TO FURTHER IMPACT THE CAGE AND THEN ATTEMPTING TO REMOVE IT APPLIED PRESSURE ON THE SPINAL CORD CAUSING A DECREASE ON THE PATIENTS SENSORY DURING SSEP MONITORING. WE EVENTUALLY REMOVED THAT CAGE AND INSERTED A SECOND ONE SUCCESSFULLY. THE SECOND CAGE WAS EVENTUALLY INSERTED CORRECTLY AND THE SAME INSERTER WAS USED TO COMPLETE THE SURGERY.
Patient problems: Injury; No Code Available
MAUDE report 6130519 ↗
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- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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