DYNATRAN 48670230Recalls & reported problems
Stryker Corporation · TWO-LEVEL PLATE · 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 07613252151678), received between Jun 14, 2018 and Jun 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
- Insufficient Device Problem Information1
Patient problems
- Autoimmune Reaction1
- Confusion/ Disorientation1
- Fatigue1
- Injury1
- Itching Sensation1
- Nerve Damage1
- Numbness1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2018Biocompatibility; Insufficient Device Problem Information; Biocompatibility
IT WAS REPORTED THAT HE PATIENT STARTED HAVING ONGOING ISSUES SINCE SURGERY WHICH INCLUDE ITCHING, FATIGUE, MYALGIA, FURTHER INTO THE YEAR HAVING GASTRO-INTESTINAL ISSUES, NECK PAIN, NUMBNESS IN ARMS AND HANDS AS WELL AS FACE, UNCOMFORTABLE SWALLOWING, SKIN BUMPS AND BREAK OUTS AROUND NECK, CHEST AND UPPER BACK, AND BRAIN FOG. PATIENT HAS HAD TESTING DONE, HAS TESTED POSITIVE AUTOIMMUNE ISSUE, (B)(6) WEIGHT LOSS IN A SHORT PERIOD WITHOUT REASON. DOC SEVERED LONG THORACIC NERVE AND DAMAGED C7 NERVE.
Patient problems: Autoimmune Reaction; Confusion/ Disorientation; Fatigue; Injury; Itching Sensation; Nerve Damage; Numbness; Pain; Reaction; Swelling; Weight Changes
MAUDE report 7603565 ↗
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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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