SpheRx 7375545Recalls & reported problems
Nuvasive, Inc. · SpheRx® DBR®II Screw, 5.5x45mm Cann Poly · Class 2 · Implant
Data updated Oct 16, 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 00887517479020), received between Aug 24, 2018 and Aug 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
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.
MalfunctionAug 24, 2018Fracture; Fracture
ON (B)(6) 2010, PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. ON (B)(6) 2017 APPROXIMATELY SEVEN YEARS POST INDEX SURGERY, PATIENT WAS EXPERIENCING BACK PAIN. RADIOGRAPHS REVEALED A PEDICLE SCREW FRACTURE AT S1 LEVEL AND A FACET SCREW FRACTURE AT THE LEFT CONTRALATERAL SIDE. ON (B)(6) 2017 A REVISION PROCEDURE WAS PERFORMED DUE TO ADJACENT SEGMENT DISORDER AND FRACTURED SCREW WAS REPLACED WITHOUT ANY REPORTED ISSUES.
Patient problems: Failure of Implant
MAUDE report 7814347 ↗
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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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