Skipjack 83-0608Recalls & reported problems
Seaspine Orthopedics Corporation · 11mm x 26mm x 8-11mm, 0 Deg · 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 10889981139889), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2018Mechanical Problem; Mechanical Problem
IN (B)(6) 2018 PATIENT UNDERWENT A TEN LEVEL (L3 - S1) SPINAL FUSION WITH SKIPJACK POSTERIOR INTERBODY FIXATION. IT WAS REPORTED PATIENT SUSTAINED A FALL, BUT FELT NO PAIN AFTER. FOLLOW-UP EXAM SHOWED SKIPJACK HAD MIGRATED/BACKED OUT POSTERIORLY. REVISION SURGERY OCCURRED (B)(6) 2018. IMPLANT WAS ADJUSTED IN THE VERTEBRAL BODY. NO REVISION ON HARDWARE. IT WAS REPORTED PATIENT FELT PAIN. FOLLOW -UP EXAM SHOWED CAGE HAD MIGRATED/ BACKED OUT POSTERIORLY FOR A SECOND TIME. 2ND REVISION SURGERY OCCURRED (B)(6) 2018. IMPLANT WAS REMOVED AND REPLACED WITH VENTURA PEEK INTERBODY. NEWPORT CONSTRUCT WAS FITTED WITH LARGER SCREWS FOR SUPPORT. IN (B)(6) 2018 PATIENT UNDERWENT A TEN LEVEL (L3 - S1) SPINAL FUSION WITH NEWPORT POSTERIOR FIXATION. SURGEON CONTINUES TO MONITOR PATIENT.
Patient problems: Fall
MAUDE report 7912505 ↗
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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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