TPSRecalls & reported problems across all models

We found 5 models of TPS by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Apr 22, 2026 — classified as 1 injury, 106 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TPS problems

TPS models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TPS 5100004000

  UNIT, OPERATIVE DENTAL
  50 reports
• TPS 5100008000

  UNIT, OPERATIVE DENTAL
  22 reports
• TPS 5100131000

  UNIT, OPERATIVE DENTAL
  17 reports
• TPS 5100007000

  UNIT, OPERATIVE DENTAL
  15 reports
• TPS 5100031000

  UNIT, OPERATIVE DENTAL
  3 reports

Recent TPS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 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 JANUARY 1 ¿ MARCH 31, 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954322 ↗
• MalfunctionApr 22, 2026Device Remains Activated

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31, 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DEVICE REMAINS ACTIVATED. 1 EVENT HAD INSUFFICIENT INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954309 ↗
• MalfunctionJan 23, 2026Device Remains Activated

  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: DEVICE REMAINS ACTIVATED. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163963 ↗
• 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 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399942 ↗
• MalfunctionJan 21, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 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 21201158 ↗
• MalfunctionJan 21, 2025Unintended Power Up; Unintended Power Up

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201036 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500482 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 4 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 19823121 ↗
• MalfunctionJul 24, 2024Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823113 ↗
• MalfunctionJul 24, 2024Unintended Power Up; Unintended Power Up

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 1 EVENT 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 19820055 ↗
• MalfunctionJul 24, 2024Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818484 ↗
• MalfunctionJul 12, 2024

  AFTER UNDRAPING, BLACK SPOTS WERE NOTICED UNDER CHIN AND ONE ON NECK. APPEARS TO BE A BURN. SURGEONS AND TECH ARE UNSURE HOW THIS COULD'VE HAPPENED BUT SPECULATE POSSIBLE BURN FROM LIGHTED RETRACTOR OR HEATED SALINE/SOOT FROM IRRIGATION RUNNING OFF OF TPS. LATER LEARNED THAT THE BLACK WAS FROM SOOT GENERATED BY HEATED LUBRICANT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19728734 ↗
• MalfunctionApr 16, 2024Unintended Power Up; Unintended Power Up

  THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. - (B)(4) EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113388 ↗
• MalfunctionApr 16, 2024Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113386 ↗
• MalfunctionApr 15, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT 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 19113337 ↗

Other Stryker Corporation products

• RemB7 models · 3,073 reports
• Prime Series21 models · 1,548 reports · 2 recalls
• TARGET114 models · 1,077 reports
• ProCuity17 models · 368 reports · 13 recalls
• Spetzler-Malis20 models · 7 reports · 19 recalls
• SYNCHRO 28 models · 313 reports · 9 recalls
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls