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NA 5100120952Recalls & reported problems

Stryker Corporation · SD/PD Series MIS Long Curved Attachment · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540494795), received between Jul 24, 2018 and Dec 12, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 reports).

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

  • Overheating of Device3
  • Break2

Patient problems

  • No Patient Involvement3
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 12, 2020Overheating of Device; Overheating of Device

    THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10996704 ↗
  • MalfunctionOct 29, 2018Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8014888 ↗
  • MalfunctionOct 29, 2018Break; Break

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Patient Involvement

    MAUDE report 8014638 ↗
  • MalfunctionJul 24, 2018Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. THE 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Patient Involvement

    MAUDE report 7714995 ↗
  • MalfunctionJul 24, 2018Break; Break

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. ONE EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Patient Involvement

    MAUDE report 7714819 ↗

Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices

All DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices →

Sources and updates

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