NA 200.816Recalls & reported problems
Synthes GmbH · 1.5MM CORTEX SCREW SELF-TAPPING 16MM · Class 2 · Implant
Data updated Oct 16, 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 10886982141552), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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
- Incomplete or Missing Packaging1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2019Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT ON AN (B)(6) 2019, THERE WAS A SHIPPING SHORTAGE OF ONE (1) 16MM MINI FRAGMENT SCREW. CUSTOMER RECEIVED THE EMPTY PACKAGE WITH NOTHING IN IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8286783 ↗
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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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