TPS 5100131000Recalls & reported problems
Stryker Corporation · XL Oscilliating Saw · Class 1
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04546540983930), received between Jul 24, 2018 and Apr 25, 2023 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component13
- Overheating of Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Patient Involvement6
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16807799 ↗MalfunctionApr 25, 2023Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16807352 ↗MalfunctionFeb 6, 2023Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302947 ↗MalfunctionFeb 6, 2023Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302946 ↗MalfunctionOct 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15666934 ↗MalfunctionOct 25, 2022Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15666726 ↗MalfunctionJul 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12203294 ↗MalfunctionApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11728532 ↗MalfunctionOct 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748492 ↗MalfunctionJul 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 10330191 ↗MalfunctionApr 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 9998443 ↗MalfunctionOct 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 9245342 ↗MalfunctionJul 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8816401 ↗MalfunctionApr 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 8546020 ↗MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8284687 ↗MalfunctionOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES <NOE> 6 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 8014639 ↗MalfunctionJul 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 7714834 ↗
Other UNIT, OPERATIVE DENTAL devices
- NA 5100015250Stryker Corporation · UNIT, OPERATIVE DENTAL131 reports
- NA 5100015270Stryker Corporation · UNIT, OPERATIVE DENTAL75 reports
- TPS 5100004000Stryker Corporation · UNIT, OPERATIVE DENTAL50 reports
- NA 5100015252Stryker Corporation · UNIT, OPERATIVE DENTAL42 reports
- TPS 5100008000Stryker Corporation · UNIT, OPERATIVE DENTAL22 reports
- NA 5100015272Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
- TPS 5100007000Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
- NA 5100009000Stryker Corporation · UNIT, OPERATIVE DENTAL5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.