VuePoint 8976030P3Recalls & reported problems
Nuvasive, Inc. · VuePoint II Conn, 30mmx45° LateralOffset · Class 2 · Implant
All models of VuePoint (26)
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 00887517830340), received between Jul 26, 2024 and Jul 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION PROCEDURE FROM C2 TO C5. THE PROCEDURE WAS PLANNED USING BILATERAL OFFSET CONNECTORS; HOWEVER, AN OFFSET CONNECTOR COULD NOT BE USED ON THE LEFT C2 SIDE BECAUSE THE LOCK SCREW WAS MOUNTED UPSIDE-DOWN AND COULD NOT BE ORIENTED CORRECTLY DURING THE PROCEDURE. THE SURGEON OPTED TO CHANGE THE SURGICAL PLAN, WHICH INCLUDED AN ADDITIONAL INCISION MADE TO INSERT THE LOCK SCREW AT THE RIGHT SIDE OF C2 AS THE INITIAL SCREW PLACEMENT WAS TURNED OUTWARD. THE DELAY AND ADDITIONAL PROCEDURAL STEPS CONTRIBUTED TO THE TOTAL OPERATIVE TIME BEING EXTENDED BY APPROXIMATELY 3 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19844565 ↗
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- 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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