NA 5100015250Recalls & reported problems
Stryker Corporation · MD Series Straight Attachment · Class 1
Quick summary
This Stryker MD Series dental attachment has 130 adverse event reports on record, with no deaths and 2 injuries. The reports mostly describe the attachment overheating, parts coming loose, or fracturing, and some mention burns. Most say no clinical signs were reported. There are no recalls naming this device. The last 12 months show 5 reports, compared with 17 in the 12 months before.
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
- 131
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 04546540380272), received between Jul 24, 2018 and Jul 22, 2026 — classified as 2 injuries, 129 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (44 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 Device44
- Detachment of Device or Device Component32
- Fracture20
- Fluid/Blood Leak16
- Material Disintegration10
- Material Fragmentation4
- Unintended Ejection4
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions102
- Burn(s)26
- No Patient Involvement20
- Insufficient Information10
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient7
- Burn, Thermal3
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25908192 ↗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 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953809 ↗MalfunctionJan 23, 2026Material Disintegration; 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 OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURES: MATERIAL DISINTEGRATION; OVERHEATING OF DEVICE. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163125 ↗MalfunctionJan 23, 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 OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163123 ↗MalfunctionJan 23, 2026Overheating of Device
NO CHANGE.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 24163076 ↗MalfunctionDec 10, 2025Overheating of Device; Overheating of Device
MalfunctionOct 28, 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 DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399939 ↗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 21 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE, 4 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT, 10 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT, 5 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT, 2 EVENTS HAD MINOR INJURY/ILLNESS/IMPAIRMENT.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 23399807 ↗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 9 EVENTS FOR THE FAILURE: FRACTURE. - 8 EVENTS 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 23399767 ↗MalfunctionJul 29, 2025Overheating of Device; Overheating of Device
NO CHANGE.
Patient problems: Burn(s); Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22649383 ↗MalfunctionJul 29, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 8 EVENTS FOR THE FAILURE: FRACTURE. 6 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647031 ↗MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646733 ↗MalfunctionJul 24, 2025Material Fragmentation; Material Fragmentation
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAGMENTATION. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587153 ↗MalfunctionJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FLUID/BLOOD LEAK. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. - 2 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587151 ↗MalfunctionApr 21, 2025Material Disintegration; Material Disintegration
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876852 ↗MalfunctionApr 21, 2025Material Fragmentation; Material Fragmentation
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876642 ↗MalfunctionApr 21, 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. 3 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876270 ↗MalfunctionApr 21, 2025Material Disintegration; Overheating of Device; Material Disintegration; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED AND WAS SHEDDING METAL DEBRIS. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21875705 ↗MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 5 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21207644 ↗MalfunctionJan 22, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 4 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; 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 21207548 ↗MalfunctionJan 21, 2025Material Fragmentation; Material Fragmentation
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE. -THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201157 ↗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 21201035 ↗MalfunctionJan 21, 2025Material Disintegration; Material Disintegration
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200140 ↗MalfunctionOct 22, 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 20501549 ↗MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 4 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20501334 ↗
Other UNIT, OPERATIVE DENTAL devices
- 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
- 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.