Stryker 0406-650-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 15060842920029), received between Sep 2, 2022 and Jun 20, 2025 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD A GROUNDING PAD BURN ON THEIR LEG. MEDICATION WAS PRESCRIBED AND THE SKIN SITE WAS NOT SHAVED.

  Patient problems: Burn(s)

  MAUDE report 22296526 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN BY THE GROUNDING PAD DURING THE RFA AND SUSTAINED A 2-3 DEGREE BURN THAT WAS UNDER THE GROUNDING PAD AND DISCOVERED AFTER THE PROCEDURE. THE PATIENT SUSTAINED A 2-3 DEGREE CLOVER SHAPED BURN THAT REQUIRED WOUND CARE FOR WEEKS AFTERWARDS TO OPTIMIZE HEALING AND REDUCE SCARRING AND CHRONIC PAIN.

  Patient problems: Burn(s)

  MAUDE report 21763747 ↗
• InjuryMar 10, 2025Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD PAIN BY THE GROUNDING PAD DURING THE RFA AND SUSTAINED A 2-3 DEGREE BURN WHERE THE GROUNDING PAD WAS. IT WAS REPORTED THAT THE PATIENT RECEIVED WEEKS OF WOUND CARE TO OPTIMIZE HEALING AND REDUCE SCARRING AND CHRONIC PAIN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21563785 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME OUT FROM OR AND PATIENT CAME OUT WITH TWO BURNS, AND PATIENT STATED THEY FELT SOMETHING DURING THE PROCEDURE. PATIENT MIGHT NEED A SKIN GRAFT OR THERE MIGHT BE A SCAR LEFT AFTER WOUND IS HEALED. STAFF APPLIED TREATMENT TO PROTECT THE WOUND AFTER THE INCIDENT.

  Patient problems: Burn(s)

  MAUDE report 19837445 ↗
• InjuryJun 7, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER CALLED IN TO REPORT A PATIENT SUSTAINED A GRADE 1-2 BURN ON THE SKIN WHERE THE GROUNDING PAD WAS PLACED - UPPER LEG/THIGH. LUMBAR RADIOFREQUENCY, PAD PLACED ON THIGH, PATIENT MOVED DURING THE PROCEDURE. THE PAD WAS RELOCATED TO CALF AFTER PATIENT MOVED. PAD WAS RELOCATED WITH NO FURTHER INCIDENT. MEDICATION WAS PROVIDED TO TREAT THE BURN SUSTAINED. SINCE MEDICAL INTERNVENTION WAS REQUIRED NMT HAS DETERMINED THIS TO BE A REPORTABLE EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19491526 ↗
• InjuryMay 10, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO NMT ON(B)(6) 2024 BY THE SALES REP THAT A PATIENT WAS BURNED BY A GROUNDING PAD. PATIENT WAS PRESCRIBED BURN MEDICATION. SALES REP STATED THE SITE PREP WAS DONE BUT THE PAD WAS PLACED ON THE CALF IN A VERTICAL ORIENTATION. BURN WAS SAID TO BE 1ST DEGREE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19289803 ↗
• InjuryApr 25, 2024Off-Label Use; Off-Label Use

  THE CUSTOMER REPORTED "WHEN I REMOVED THE GROUNDING PAD, I SAW THAT PATIENT HAD ABOUT 5 FOCAL SPOTS OF SKIN BURNS, WITH RED AND YELLOW DISCOLORATION, CONSISTENT WITH SECOND DEGREE BURN." THE PROCEDURE WAS COMPLETE BUT THE PATIENT HAD COMPLAINED OF BURNING DURING THE PROCEDURE AND THEN IDENTIFIED A BURN AFTER THE PROCEDURE. THE SKIN WAS NOT SHAVED PER THE IFU. HOWEVER THE CUSTOMER STATED THEY NORMALLY DON'T SHAVE AND HAVE NEVER HAD THIS ISSUE. THE PAD WAS ORIENTED AND POSITIONED ON THE THIGH ACCORDING TO THE IFU. CUSTOMER REPORTED "PATIENT WAS TREATED WITH INTRAMUSCULAR TORADOL, ICE PACK AND TOPICAL SILVER SULFADIAZINE. PATIENT WAS DISCHARGED WITH ICE PACKS, AND SILVER SULFADIAZINE. TODAY I CALLED THE PATIENT AND HE STATES THE PAIN IS UNDER CONTROL, BUT HE HAD A BLISTER THE SIZE OF A QUARTER WHICH HAD BURST SINCE MEDICAL INTERVENTION WAS INVOLVED, NMT HAS DEEMED THIS A REPORTABLE EVENT.

  Patient problems: Burn(s)

  MAUDE report 19179174 ↗
• InjuryJun 12, 2023Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED BY THE GROUNDING PAD, THE BURN WAS NOTICED WHEN THE PAD WAS REMOVED. THIS WAS A 3RD DEGREE BURN AND WAS TREATED WITH MEDICINE AND A BANDAGE BY THE DOCTOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAYS TAKING PLACE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17108949 ↗
• MalfunctionJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED AND BURN FROM THE GROUNDING PAD. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO MEDICAL INTERVENTION OR SURGICAL DELAYS. WE HAVE CONTACTED THE CUSTOMER MULTIPLE TIMES TO GET ADDITIONAL INFORMATION BUT HAVE NOT RECEIVED A RESPONSE TO DATE.

  Patient problems: Burn(s)

  MAUDE report 17099556 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLETED A RF LUMBAR ABLATION AND CALLED THE FOLLOWING WEEK STATING HE HAD SUSTAINED A BURN ON HIS HIP. THE PATIENT STATED THE BURN STARTED RIGHT AFTER HIS PROCEDURE. THE PATIENT WENT TO A CLINIC AND WAS TREATED WITH ANTIBIOTICS FOR WHAT THE PATIENT SAID WAS A 3RD DEGREE BURN. IT SHOULD BE NOTED THAT THE CUSTOMER STATED THERE WERE NO ISSUES IN THE OR AND NO ONE REMEMBERS ANY ALARMS DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17022183 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLETED A RF LUMBAR ABLATION AND CALLED THE FOLLOWING WEEK STATING HE HAD SUSTAINED A BURN ON HIS HIP. THE PATIENT STATED THE BURN STARTED RIGHT AFTER HIS PROCEDURE. THE PATIENT WENT TO A CLINIC AND WAS TREATED WITH ANTIBIOTICS FOR WHAT THE PATIENT SAID WAS A 3RD DEGREE BURN. IT SHOULD BE NOTED THAT THE CUSTOMER STATED THERE WERE NO ISSUES IN THE OR AND NO ONE REMEMBERS ANY ALARMS DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17018413 ↗
• InjuryMay 19, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT RECEIVED A BURN AT THE GROUNDING PAD SITE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS. THE PATIENT CAME IN 4 WEEKS LATE FOR A FOLLOW UP AND WAS REFERRED TO THE WOUND CARE CLINIC FOR TREATMENT ON THE BURN. WE HAVE REACHED OUT TO THE CUSTOMER TO SEE ABOUT OBTAINING ADDITIONAL DETAILS ABOUT THE EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16961484 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED BY THE GROUNDING PAD, THE BURN WAS NOTICED WHEN THE PAD WAS REMOVED. THIS WAS A PARTIAL 3RD DEGREE BURN AND A SKIN GRAFT HAS BEEN SCHEDULED. THE SALES REPRESENTATIVE IS TRYING TO GATHER WHEN THIS MAY TAKE PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAYS TAKING PLACE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 16915037 ↗
• InjuryMay 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023 THE UK FACILITY HAS RECEIVED A CUSTOMER COMPLAINT FROM THE CUSTOMER STRYKER REGARDING: - IT WAS REPORTED THAT THE PATIENT WAS BURNED BY THE GROUNDING PAD, BURNED NOTICED WHEN PAD WAS REMOVED. ADDTIONAL TREATMENT MAY NEED TO BE PROVIDED. UNKNOWN WHAT DEGREE OF BURN. PATIENT HAS BEEN SCHEDULED FOR A SKIN GRAFT. NO LOT PROVIDED. CUSTOMER STATES THE DEVICE WILL BE RETURNED FOR EVALUATION. TO DATE, NO RETURN RECEIVED.

  Patient problems: Burn(s)

  MAUDE report 16848652 ↗
• InjuryMar 6, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023 THE UK FACILITY HAS RECEIVED A CUSTOMER COMPLAINT FROM THE CUSTOMER STRYKER. REGARDING: IT WAS REPORTED THAT THE GROUNDING PAD BURNED THE PATIENT DURING THE PROCEDURE. OCCURRED ON (B)(6) 2023. STRYKER GROUNDING PAD THAT WAS ORDERED FOR MG2 RF GENERATOR BURNED PT LEG DURING PROCEDURE INCIDENT OCCURRED DURING PROCEDURE. PT WAS BURNED ON BACK OF LEFT THIGH. PT WAS GIVEN ANTIBIOTIC CREAM AND PHYSICIAN WILL MONITOR. NO DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SKIN PREP TO THE NECK AND PACK WAS CLEAR CHLORAPREP. THE SKIN PREP TO THE GROUNDING PAD SITE WAS NONE. PT. HAD SOME HAIR, BUT NOT EXCESSIVE. CUSTOMER STATES THEY WERE NOT GIVEN THE UPDATED RECOMMENDATIONS FOR THESE GROUNDING PADS UNTIL AFTER THE INCIDENT. THE GENERATOR DID NOT MALFUNCTION. THE SETTINGS WERE ON 85 DEGREES CELSIUS FOR 90 SECONDS. MD DICTATED SECOND DEGREE BURN. DUE TO THE MDICAL INTERVENTION TO PRECLUDE IMPAIRMENT, NISSHA MEDICAL TECHNOLOGIES LIMITED HAS FOUND THIS TO BE A REPORTABLE EVENT.

  Patient problems: Burn(s)

  MAUDE report 16491246 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RECEIVED POTENTIAL 2ND DEGREE BURN AFTER RFA. GROUNDING PAD WAS ON LEFT UPPER BACK AND BURN WAS NOTED 2 DAYS AFTER PROCEDURE HIS SKIN BLISTERED. HE NEEDED TO BE TREATED BY BURN/WOUND CARE FOR A MONTH BUT COMPLETELY HEALED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAYS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16378908 ↗
• InjuryFeb 14, 2023Use of Device Problem; Use of Device Problem

  ON 27TH JANUARY 2023 RECEIVED A CUSTOMER COMPLAINT REGARDING: IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT RECEIVED A MINOR BURN ON THE SKIN. THE PATIENT WAS BURNED ON THE SKIN. IT IS A 2 INCH BURN ALONG THE GROUND PAD. THE GROUND PAD WAS PLACED ON THE PATIENT'S LEFT THIGH AND EXTENDED ALONG THE CROSS OF THE KNEE. THE PATIENT WAS PRONE (FACE DOWN) AND THE PAD WAS PLACED ON THE BACKSIDE OF THE HAMSTRING, WITH PART OF THE PAD EXTENDING ACROSS THE CREASE IN THE BACKSIDE OF THEIR KNEE. SEVERAL PADS FROM THE SAME LOT USED IN EARLIER CASES AND AFTER THIS CASE WITHOUT ANY ISSUES. PATIENT SUSTAINED 2ND DEGREE BURNS AND WAS TREATED WITH CREAM. DUE TO THE MEDICAL INTERVENTION TO PRECLUDE IMPAIRMENT, NISSHA MEDICAL TECHNOLOGIES LIMITED HAS FOUND THIS TO BE A REPORTABLE EVENT.

  Patient problems: Burn(s)

  MAUDE report 16372636 ↗
• InjuryFeb 14, 2023Use of Device Problem; Use of Device Problem

  ON 19TH JANUARY 2023 RECEIVED A CUSTOMER COMPLAINT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT SUFFERED A BURN AT THE GROUNDING PAD SITE. BURN WAS NOT DISCOVERED UNTIL AFTER PROCEDURE WAS DONE. THERE MAY HAVE BEEN A BLISTER, BUT NOT CONFIRMED, CONSIDERED 2ND DEGREE BURN. A BANDAGE AND OINTMENT WAS USED ON THE BURN. CUSTOMER SENT GENERATOR BACK AND SALES REP WILL TRY TO SECURE GROUND PAD WE DO NOT KNOW THE LOT/SERIAL NUMBER. DOCTOR STATED THE GROUNDING PAD PLACEMENT AND PREP MAY HAVE BEEN AN ISSUE. CASES BEFORE AND AFTER THIS ONE WERE COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED ISSUES WITH THE GENERATOR. DUE TO THE MEDICAL INTERVENTION TO PRECLUDE IMPAIRMENT, NISSHA MEDICAL TECHNOLOGIES LIMITED HAS FOUND THIS TO BE A REPORTABLE EVENT.

  Patient problems: Burn(s)

  MAUDE report 16372138 ↗
• MalfunctionFeb 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY SALES REP THAT CUSTOMER HAD A GROUNDING PAD ON THEIR LEG AND THEY ALSO HAD EXTENSIVE AMOUNT OF HAIR ON THEIR LEG. THE PATIENT DID SUFFER A SMALL BURN AT THE GROUNDING PAD SITE. THE PROCEDURE WAS COMPLETE WITHOUT ANY DELAYS OR MEDICAL INTERVENTION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16354173 ↗
• MalfunctionDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BURN AT THE GROUNDING PAD SITE, IT WAS NOTED THAT GROUNDING PAD GEL HAD DRIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS OR MEDICAL INTERVENTION. A TOPICAL CREAM WAS USED TO TREAT THE BURN AND PREVENT INFECTION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15931122 ↗
• MalfunctionSep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN RF ABLATION PROCEDURE BURNS WERE FOUND ON THE PATIENT WHERE THE RETURN ELECTRODE WAS PLACED. ADDITIONAL DETAIL AROUND THE EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 15348382 ↗