mild Device Kit MDK-0001 (UDI 07613327651683)Recalls & reported problems
Stryker Corporation · Device Kit · Class 2
All models of mild Device Kit (3)
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 07613327651683), received between Apr 16, 2026 and Apr 16, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Atrophy1
- Neuropathy1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
EVENT WAS REPORTED BY PATIENT VIA MEDWATCH. THE PATIENT STATED THAT DURING A MILD PROCEDURE, THE DOCTOR REMOVED OLD SCAR TISSUE FROM A PREVIOUS TWO-LEVEL SPINAL FUSION INSTEAD OF THE LIGAMENTUM FLAVUM, WHICH CAUSED NERVE ISSUES. THE PATIENT ALLEGED THAT THE SCAR TISSUE REMOVAL LED TO PERMANENT DISABLEMENT AND MAJOR MUSCLE ATROPHY IN EVERY MUSCLE THAT THE S1 INNERVATES. THE PATIENT STATED THIS ALSO CAUSED CAUDA EQUINA SYNDROME AND ARACHNOIDITIS. BASED ON THE INFORMATION PROVIDED, THERE WAS NO MALFUNCTION OF THE MILD DEVICE.
Patient problems: Atrophy; Neuropathy; Pain
MAUDE report 24904533 ↗
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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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