OASYS 48551046Recalls & reported problems
Stryker Corporation · LARGE, MIDLINE OCCIPUT PLATE · Class 2 · Implant
All models of OASYS (60)
Data updated Oct 16, 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 04546540616555), received between Jun 6, 2017 and Jun 6, 2017 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Fracture1
Patient problems
- Injury1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2017Break; Detachment Of Device Component; Fracture; Fracture
IT WAS REPORTED THAT; PATIENT WAS IN A NECK COLLAR FOR 6 WEEKS, PATIENT THEN REMOVED COLLAR AND ALLEGEDLY HEARD A CLUNK AND REPORTED ASSOCIATED PAIN. PATIENT CAME EMERGENCY. IMAGING NOTED THAT THE C6 SCREWS WERE PULLED OUT AND C2 UNILATERAL TRANSLAMINAR SCREW AS WELL. THE ACCOUNT DID NOT NOTICE THAT THE OCCIPUT PLATE WAS BROKEN DURING IMAGING BUT DURING THE REVISION PROCEDURE IT WAS REPORTED AS BROKEN. PHYSICIAN REMOVED THE OCCIPITAL PLATE AND REPLACED IT WITH THE SAME PART AND EXTENDED THE FUSION TO T2 (T1 AND T2 SCREWS WERE ADDED WHILE C1 AND C2 WERE LEFT UNINSTRUMENTED).
Patient problems: Injury; Pain
MAUDE report 6614001 ↗
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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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