SpheRx 7782001Recalls & reported problems
Nuvasive, Inc. · SpheRx® PPS Lock Screw, 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 00887517121714), received between Jun 20, 2019 and Jun 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2019 PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE DURING WHICH A LOCK SCREW STRIPPED DURING PLACEMENT BUT WAS LEFT IN PLACE. ON (B)(6) 2019 RADIOGRAPHS IDENTIFIED THE LOCK SCREW BACKED OUT AND DISENGAGED. ON (B)(6) 2019 A REVISION PROCEDURE TOOK PLACE WITH ANOTHER SURGEON WHERE THE BACKED OUT LOCK SCREW WAS REPLACED WITHOUT A REPORTED ISSUE. NO PATIENT INJURY REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8719354 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
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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