NA 5100015270Recalls & reported problems
Stryker Corporation · MD Series Long Straight Attachment · Class 1
Quick summary
This Stryker MD Series long straight attachment is a handpiece used for operative dental surgery. The 73 reports mostly describe the attachment overheating during use, parts coming loose or breaking off, and burns to the patient's mouth;1 report involved an injury and there were no deaths. Most events were caught before clinical use or found outside a patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 04546540380289), received between Jul 24, 2018 and Jul 22, 2026 — classified as 1 injury, 74 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (30 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device30
- Detachment of Device or Device Component26
- Fracture14
- Break1
- Fluid/Blood Leak1
- Material Disintegration1
- Mechanical Jam1
- Unintended Ejection1
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Patient Involvement13
- Burn(s)9
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient3
- Burn, Thermal1
- Full thickness (Third Degree) Burn1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25907807 ↗MalfunctionJul 22, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25907616 ↗MalfunctionApr 22, 2026Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953797 ↗MalfunctionApr 22, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953791 ↗MalfunctionJan 23, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163764 ↗MalfunctionJan 23, 2026Overheating of Device
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163115 ↗MalfunctionOct 28, 2025Fracture; Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: FRACTURE. 2 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399938 ↗MalfunctionOct 28, 2025Overheating of Device; Overheating of Device
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 7 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 7 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399925 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368864 ↗MalfunctionJul 30, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 2 EVENTS HAD MINOR INJURY/ ILLNESS / IMPAIRMENT. 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 22663293 ↗MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 2 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587164 ↗MalfunctionApr 21, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876648 ↗MalfunctionApr 21, 2025Detachment 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. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876258 ↗MalfunctionJan 22, 2025Detachment 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. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21207499 ↗MalfunctionJan 21, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201165 ↗MalfunctionJan 21, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. -THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201161 ↗MalfunctionOct 21, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 7 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 20499633 ↗MalfunctionJul 24, 2024Detachment 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 19823253 ↗MalfunctionJul 24, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823127 ↗MalfunctionJul 24, 2024Unintended Ejection; Unintended Ejection
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY UNINTENTIONALLY EJECTED THE CUTTING DEVICE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19820453 ↗MalfunctionJul 24, 2024Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19816040 ↗MalfunctionApr 16, 2024Fracture; Fracture
THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - (B)(4) EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19113393 ↗MalfunctionApr 16, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19113390 ↗MalfunctionJan 22, 2024Detachment 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 18556452 ↗MalfunctionOct 23, 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 17993154 ↗
Other UNIT, OPERATIVE DENTAL devices
- NA 5100015250Stryker Corporation · UNIT, OPERATIVE DENTAL131 reports
- TPS 5100004000Stryker Corporation · UNIT, OPERATIVE DENTAL50 reports
- NA 5100015252Stryker Corporation · UNIT, OPERATIVE DENTAL42 reports
- TPS 5100008000Stryker Corporation · UNIT, OPERATIVE DENTAL22 reports
- TPS 5100131000Stryker Corporation · UNIT, OPERATIVE DENTAL17 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.