SpheRx 7782004Recalls & reported problems
Nuvasive, Inc. · SpheRx® PPS Tulip, 5.5mm Rod · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517121738), received between Jun 13, 2017 and Jun 13, 2017 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Unintended Movement1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2017Detachment Of Device Component; Unintended Movement; Detachment Of Device Component; Unintended Movement
ON (B)(6) 2017, A PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE AT L5. POSTOPERATIVELY, IT WAS REPORTED A TULIP, ROD AND LOCK SCREW DISENGAGED FROM THE SHANK. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 6637395 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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