Solanas 63035-16Recalls & reported problems
Alphatec Spine, Inc. · POLYAXIAL POSTERIOR THORACIC SCREW, Ø3.5mm X 16mm · Class 2 · Implant
Data updated Oct 13, 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 00844856006607), received between Dec 13, 2016 and Dec 13, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Failure of Implant1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2016Break; Fracture; Device Dislodged or Dislocated
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT A YOUNG MALE PATIENT WITH GOOD BONE QUALITY UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE 3 BROKE SOLANAS SCREWS ON (B)(6) 2016. THE SCREWS FRACTURED BROKE MID-WAY OF THE THREADED SHAFT AT THE C6 AND C7. THE PROXIMAL SECTIONS OF THE SCREWS WERE REMOVED WITHOUT ISSUE, WHILE THE DISTAL THREADED PORTIONS REMAIN ENTRAPPED WITHIN THE PATIENTS C6/C7 CERVICAL VERTEBRAE'S. THE SOLANAS FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2016.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 6170634 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- 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 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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