Biomet EBI Bone Healing System 1068226Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00812301020515), received between Sep 13, 2019 and Jan 7, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (15 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THEIR FOOT AND STATED THAT THEIR FOOT FELT LIKE IT WAS BURNING. IT WAS LATER REPORTED THAT THE SFLX 2 COIL GIVES THE PATIENT A BURNING SENSATION ON THEIR FOOT. SOME NIGHTS THE BURNING SENSATION IS RATED AT A 10 OUT OF 10. AFTER TREATING AT NIGHT, THE PATIENT RATED THE BURNING SENSATION A 3 OUT OF 10. THE PATIENT SHARED THEY ARE STILL WEARING THE BOOT WHILE TREATING EVEN THOUGH THE DOCTOR TOLD THEM THEY DO NOT NEED TO. THE PATIENT DID NOT DISCUSS THE BURNING SENSATION WITH THEIR DOCTOR AND DID NOT USE ANY CREAMS. THE SKIN IS RED AND PAINFUL WITH NO BLISTERS AND NO BUMPS. THE PATIENT NORMALLY USES THE DEVICE STARTING AROUND 10PM AND WAKES UP FEELING THE BURN BY 3-5 AM EVERY NIGHT. THE PATIENT NOTED THAT THERE WERE NO ISSUES WITH THE ORIGINAL SFLX 2 COIL RECEIVED IN THE ASSEMBLY, THE BURNING SENSATION BEGAN WITH THE REPLACEMENT SFLX 2 COIL. A NEW SLFX 2 COIL WAS SHIPPED TO THE PATIENT.

  Patient problems: Pain; Skin Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 23990049 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TERRIBLE PAIN DURING THE NIGHT THAT OFTEN WOKE HER UP. THE PATIENT BELIEVES IT IS THE BONE GROWTH STIMULATOR. THE PATIENT WEARS THE DEVICE FROM 8PM TO 6AM EVERY NIGHT. ON (B)(6) 2025, THE PATIENT REMOVED THE DEVICE AT MIDNIGHT BECAUSE HER FOOT HURT SO MUCH AND REALIZED AFTER ABOUT 30 MINUTES SHE HAD NO PAIN. THE PATIENT STATED THAT SHE DOES NOT EXPERIENCE ANY PAIN DURING THE DAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 22999329 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN IN THE KNEE WHILE USING THE BHS ASSEMBLY. THE PATIENT DID NOT INDICATE THE PAIN LEVEL.

  Patient problems: Pain

  MAUDE report 22685691 ↗
• InjuryJul 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Pain

  MAUDE report 22644446 ↗
• InjuryJan 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT WHENEVER THE PATIENT WEARS THE STIMULATOR NO ONE IS ABLE TO WAKE HER UP. THE PATIENT ALSO MENTIONED THAT SINCE WEARING THE STIMULATOR, EVERYONE IN THE HOUSE HAS HAD HEADACHES, INCLUDING HERSELF. THE PATIENT STATED HER BROTHER AND SISTER-IN-LAW GET A HEADACHE WHILE SHE IS USING THE UNIT. THE FAMILY MEMBERS WERE IN THE SAME ROOM WHILE SHE WAS TREATING. NO MEDICAL DEVICES IMPLANTED. THE PATIENT DOES NOT HAVE A PACEMAKER OR DEFIBRILLATOR. THE PATIENT MENTIONED THAT SHE HAD NOT USED THE DEVICE IN THREE DAYS. THE PATIENT WAS INSTRUCTED TO CONTACT HER DOCTOR AND NOT TO USE THE UNIT UNTIL IT WAS APPROVED BY HER DOCTOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Headache; Sleep Dysfunction

  MAUDE report 21287676 ↗
• InjuryJan 24, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT IS FEELING DISCOMFORT WHILE WEARING HER BHS UNIT WITH SFLX COIL 2. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT REGARDING THE COMPLAINT. THE PATIENT STATED THAT THE FIRST DAY SHE WAS HAVING PAIN STABBING PAIN WHILE SHE WAS ON HER LEG. THE PATIENT WORE IT FOR 3 DAYS STRAIGHT WITH PAIN. THE PATIENT DID NOT CONTACT HER DOCTOR. THE COIL IS NOT TOO TIGHT. THE PAIN IS BELOW SKIN. THE PAIN LEVEL IS BETWEEN 8-10. SHE TOOK TYLENOL. THE PAIN DOES NOT GO AWAY WHEN SHE IS NOT WEARING THE UNIT. THE PATIENT HAS SOME PAIN WHEN NOT USING THE STIMULATOR BUT AS SOON AS SHE WEARS IT, PAIN INCREASES. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITY. THE PATIENT WILL CONDUCT A TIME TEST. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS CONTROLLER AND SFLX-2 COIL WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 21232952 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE FRACTURE SITE WHILE USING THE BHS. IT WAS LATER REPORTED THE PAIN WAS BELOW THE SKIN. THE PATIENT HAD NOT RECENTLY INCREASED THEIR LEVEL OF ACTIVITY. THE PATIENT RATED THE PAIN LEVEL AS 9 OUT OF 10. THE PATIENT CALLED THEIR DOCTOR BUT HAD TO LEAVE A MESSAGE FOR A CALL BACK. THE PAIN BEGAN ON (B)(6) 2024, AND THE PATIENT TREATED FOR THE LAST TIME ON (B)(6) 2024. THE PATIENT HAS NOT EXPERIENCED ANY MORE PAIN SINCE STOPPING TREATMENT, AND STATED THE PAIN STOPPED WITHIN SECONDS OF REMOVING THE DEVICE.

  Patient problems: Pain

  MAUDE report 21136874 ↗
• InjuryNov 15, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WORE THE DEVICE TO SLEEP AND WOKE UP WITH VARIOUS SYMPTOMS. THE PATIENT REPORTED NUMBNESS IN BOTH ARMS, ALL OVER BODY WEAKNESS, MUSCLE AND JOINT PAIN, AND THAT HER LEFT KNEE GAVE UP ON HER.

  Patient problems: Muscle Weakness/Atrophy; Numbness; Pain

  MAUDE report 20696352 ↗
• InjuryMay 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD PAIN ON HIS LEG FROM THE PRESSURE ON THE COIL. THE PATIENT GETS PAIN EVEN FROM WEARING PANTS. THE LEG IS VERY SENSITIVE TO ANYTHING TOUCHING HIS LEFT LEG. THE PAIN LEVEL WAS NOTED TO BE AN 8 OUT OF 10, ESPECIALLY WHEN MOVING. THE PATIENT HAS TO SHAVE HIS LEG BECAUSE WHEN THE HAIR MOVES IT IS VERY PAINFUL. THE PATIENT IS TAKING IBUPROFEN 800MG AND TYLENOL. THE PATIENT HAD AN APPOINTMENT WITH THEIR DOCTOR ON (B)(6) 2024. THE SALES REPRESENTATIVE WAS LOOKING INTO SWITCHING THE DEVICE AS THE PATIENT DOES NOT THINK THAT HE CAN WEAR THE BONE HEALING SYSTEM (BHS) DEVICE ANYMORE. IT WAS LATER REPORTED THAT THE PATIENT HAD NOT SPOKEN TO HIS DOCTOR YET BECAUSE THE DOCTOR WAS DIFFICULT TO GET A HOLD OF. THE PATIENT CONTINUES TO WEAR THE DEVICE BUT STATED IT FEELS LIKE IT IS BREAKING HIS LEG. THE PATIENT BELIEVES THE ACCIDENT HE WAS IN MAY HAVE MISPLACED MUSCLES IN HIS LEG OR CAUSED SOFT TISSUE DAMAGE. THE PATIENT HAS NOT RECENTLY INCREASED DAILY ACTIVITIES. HE AS ACTUALLY DECREASED DAILY ACTIVITIES DUE TO THE PAIN. THE PATIENT STATED HE WAS GOING TO CONTACT THE STATES REPRESENTED ABOUT SWITCHING TO A DIFFERENT DEVICE OR STOP WEARING THE UNIT. IT WAS LATER

  Patient problems: Limb Pain

  MAUDE report 19423967 ↗
• InjuryApr 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT SAID WITH THE DEVICE THAT THE PAIN IS WORSE. THE PATIENT STATED THAT SHE HAD A DOCTOR VISIT WHERE HE CHANGED HER SPLINT, AND SHE WAS AT A PAIN LEVEL OF 12 OUT OF 10. THE FIRST DAY SHE USED OUR BHS THE PATIENT EXPERIENCED DISCOMFORT IN ALL OF HER TOES ON THAT FOOT AT ALL OF THE OPERATIVE SITES. HER PAIN LEVEL WAS AT A 7 OR 8 OUT OF 10 WHILE TREATING WITH THE DEVICE. THE PATIENT CLAIMS NO NEW ACTIVITIES AS SHE IS NON-WEIGHT-BEARING. ON SATURDAY AND SUNDAY, HER TREATMENT TIME WAS FOR APPROXIMATELY 7 HOURS AND ON BOTH DAYS THE PAIN LEVEL WAS AT A 7 OR 8 OUT OF 10. ON MONDAY, THE PATIENT'S TREATMENT TIME WAS 10 HOURS, AND HER PAIN LEVEL WAS A 10 OUT OF 10. THE PATIENT ADVISED SHE HAS REGULARLY BEEN ON PAIN MEDICATION SINCE HER SURGERY. THE PATIENT ALSO STATED THAT AT TIMES THE PAIN MEDICATIONS DO NOT HELP HER PAIN. THE PATIENT ADVISED SHE HAS SOME RELIEF WHEN SHE TURNS OFF THE DEVICE, BUT SHE "GRINS AND BEARS¿ THE PAIN WHILE TREATING. THE PATIENT CLAIMS SHE HAS SWELLING WITH OR WITHOUT THE DEVICE. THE PATIENT ALSO STATED THAT SHE HAS AN INTERMITTENT LOW-GRADE FEVER SINCE BEFORE SHE STARTED USING OUR DEVICE. THE PATIENT CALLED AND SPOKE WITH THE PHYSICIAN

  Patient problems: Pain

  MAUDE report 19102405 ↗
• InjuryNov 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT HE WAS HAVING PAIN AND BURNING SENSATION WHILE USING THE UNIT. THE PAIN STARTED ABOUT A MONTH AFTER RECEIVING THE UNIT. THE PATIENT'S RATED THE PAIN AS AN 8 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT DID NOT INCREASE HIS DAILY ACTIVITY. THE PATIENT SPOKE WITH HIS DOCTOR AND WAS TOLD TO CALL SALES REPRESENTATIVE THE PATIENT TOOK TYLENOL, BUT IT DID NOT HELP. THE PATIENT WAS ADVISED TO CONDUCT A TIME TEST AFTER HE WAS PAIN FREE. THE PATIENT WAS ADVISED TO CALL BACK WITH ANY ISSUES DURING THE TIME TEST. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 18151761 ↗
• InjuryNov 16, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT STATING THAT HIS BHS DEVICE (SFLX 2 COIL) IS MAKING HIS FRACTURE AND ELBOW HURT WORSE AFTER TREATMENT. THE PATIENT TREATS FOR 7 HOURS PER DAY AND HAS NO ISSUE WHILE TREATING BUT AFTER THE DEVICE IS TURNED OFF. HE STATES THAT 15 MINUTES LATER HE HAS SHARP PAIN. THE PATIENT RATES THE PAIN LEVEL AN 8 OUT OF 10. THE PATIENT CLAIMS MOST DAYS SINCE HIS INJURY HE IS AT A TWO ALL DAY LONG. THE PATIENT¿S DOCTOR IS PRESCRIBING PAIN MANAGEMENT FOR HIS CONTINUOUS PAIN. THE PATIENT HAS COMPLETED PHYSICAL THERAPY. HE SOMETIMES OVEREXERTS HIMSELF BY LIFTING THINGS THAT ARE TOO HEAVY OR USING HIS INJURED ARM TO LEAN ON TO STAND UP AFTER SITTING ON THE FLOOR. HE ALSO CLAIMS HIS DOCTOR HAS TOLD HIM NOT TO DO THESE THINGS AND TO REST HIS ARM ALL DAY. ZIMVIE CUSTOMER SERVICE REPRESENTATIVE ADVISED TO PAUSE TREATMENT FOR A COUPLE DAYS THEN PERFORM A TIME TEST AND GRADUALLY WORK HIS WAY BACK TO 7 HOURS PER DAY IF TOLERATED. THE PATIENT AGREED. NO FURTHER CONSEQUENCE HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 18150445 ↗
• InjuryOct 17, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SKIN IRRITATION AND DISCOMFORT WHILE TREATING WITH THE BHS DEVICE AND COIL. THE PATIENT EXPLAINED THE UNIT IS CAUSING A RASH AND CAUSING A BURNING SENSATION. THE IRRITATION IS ON THE ANKLE WHERE SHE WEARS THE COIL. THE PATIENT ADVISED THE PAIN STARTED ABOUT 1 WEEK AGO, THE PATIENT RATED THE PAIN AS AN 10 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST AND ON THE SURFACE OF THE SKIN. THE PATIENT CLAIMS THE PAIN SUBSIDES A LITTLE WHEN SHE IS NOT TREATING. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITIES AND DID NOT SEEK MEDICAL TREATMENT. THE PATIENT IS USING BENADRYL CREAM ON THE AFFECTED AREA. THE PATIENT WILL CONTACT HER DOCTOR AND CALL CUSTOMER SERVICE BACK WITH AN UPDATE. THE PATIENT WAS ADVISED TO PAUSE TREATMENT UNTIL THE PAIN SUBSIDES THEN CONDUCT A TIME TEST. THE PATIENT STOPPED WEARING THE STIMULATOR AND IT IS HEALING. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 17951132 ↗
• InjuryMay 25, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND/OR CRAMPING WHILE USING THE BHS DEVICE. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT TO COLLECT ADDITIONAL DETAILS BUT HAD TO LEAVE A VOICEMAIL. NO REPLACEMENTS ITEMS NOTED. IT WAS REPORTED BY THE PATIENT THAT THE CRAMPING HAPPENS RIGHT AFTER HE FINISHES TREATING FOR ABOUT 2 HOURS. IT IS LIKE A CHARLEY HORSE. THE PATIENT FEELS LIKE A MUSCLE SPASM BELOW THE SKIN. THE PATIENT STATED THAT HE FEELS A LITTLE TWINGE WHILE WEARING THE UNIT. THE PATIENT STATED THAT THE PAIN LEVEL IS A 9 AND IT WAKES HIM UP. THE PAIN STARTS IN ABOUT 10 TO 20 MINUTES AFTER HE FINISHES TREATING. THE PATIENT HAS NOT INCREASED HIS DAILY ACTIVITY. THE PATIENT IS IN A WHEELCHAIR. THE PATIENT SPOKE TO HIS DOCTOR AND WAS TOLD TO JUST TAKE TYLENOL. THE DOCTOR TOLD THE PATIENT TO STOP USING THE BHS. THE PATIENT ALSO STATED THAT THE PIGTAIL IS COMING OFF THE DEVICE. THE CUSTOMER SERVICE REPRESENTATIVE SPOKE WITH THE PATIENT ABOUT THE ORTHOPAK AND THE PATIENT SAID IF HIS DOCTOR APPROVES THE SWITCH HE WILL TRY IT. CUSTOMER SERVICE REPRESENTATIVE CONTACTED THE SALES REPRESENTATIVE TO MAKE THEM AWARE OF THE CONVERSATION WITH THE PATIENT. NO ADDITIONAL INFORMA

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 17004636 ↗
• InjuryMay 25, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE PAIN WHILE TREATING WITH THE BHS DEVICE. THE PATIENT STATED THAT IT WAS DISCOMFORT AT THE BEGINNING AT NIGHT WHILE USING THE DEVICE. IN FEBRUARY THE PATIENT STOPPED USING THE STIMULATOR BECAUSE IT WAS CAUSING DISCOMFORT AND THE FOOT WAS WARM BUT NOT TO THE TOUCH. THE DOCTOR AT THAT TIME TOLD HER TO STOP USING THE DEVICE AS THE PATIENT NEEDED ANOTHER SURGERY. THE DOCTOR ALSO TOLD THE PATIENT THAT THE FOOT WAS HOT BECAUSE SHE HAD A LOT OF METAL IN IT. THE PAIN WAS BELOW THE SKIN. THE PAIN LEVEL WHILE TREATING WAS A 6 OR A 7. THE PAIN WENT AWAY ALMOST IMMEDIATELY WHEN THE STIM WAS TAKEN OFF. THE DAILY ACTIVITY WAS NOT INCREASED. THE PATIENT SPOKE TO DOCTOR. THE DOCTOR DID NOT PRESCRIBE ANYTHING FOR THE PAIN. THE PATIENT WAS TAKING ADVIL FOR THE PAIN. THE PATIENT HAD THE SECOND SURGERY. SINCE THEN, THE PATIENT USED THE DEVICE RIGHT AT THE BEGINNING AND IT WAS VERY PAINFUL. THE DOCTOR TOLD THE PATIENT TO STOP USING THE DEVICE UNTIL SHE WAS IN A CAST. WHEN SHE WAS ON A CAST, THE PATIENT TRIED AGAIN BUT IT WAS REALLY PAINFUL. SHE TRIED IT AGAIN YESTERDAY. THE PAIN WAS BAD AFTER AN HOUR AND A HALF. THE PATIENT TOOK OFF THE UNIT AT THAT TIME. THE

  Patient problems: Burning Sensation; Pain

  MAUDE report 17002642 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VIBRATION, NERVES, SHOCKS, AND TIGHTNESS WHILE TREATING WITH BHS DEVICE (COIL). THE PATIENT TOLD THE DOCTOR THAT HE FELT A MINOR VIBRATION AND HEARD A HUMMING SOUND. THE DOCTOR TOLD THE PATIENT THAT IT WAS NORMAL. THE PATIENT CONTINUED TO USE THE DEVICE UNTIL LAST SUNDAY. THE CAST WAS REMOVED, BUT BEFORE THE CAST WAS REMOVED, THE PATIENT TOLD THE CLINIC THAT SHOOTING NEURALGIA HAD WORSENED WITH THE USE OF THE DEVICE. THE DOCTOR INSTRUCTED THE PATIENT TO SWITCH TO A SMALLER COIL AS THE FUSION PROGRESSED. AFTER THE CAST WAS REMOVED, THE PATIENT SAID THAT INCREASING MEANT MORE FREQUENT AND CONSTANT. THE PAIN INCREASED. PAIN IS NOT ON THE SURFACE OF THE SKIN. PAIN LEVEL IS AROUND 7. THE DOCTOR ASKED THE PATIENT TO CONTINUE USING THE STIMULATOR. EVEN WHEN THE PATIENT TURNS OFF THE DEVICE, THE SHOOTING NERVE PAIN REMAINS. HOWEVER, AS THE PATIENT RECEIVES TREATMENT, THE PAIN INCREASES AND PERSISTS. SINCE THE CAST WAS REMOVED, THE PATIENT STATED THAT THE APPLIANCE CAUSED TENSION DURING TREATMENT AND INCREASED SPASMS. THE PATIENT SAID THAT ON SUNDAY, WITHOUT USING THE DEVICE, HE BEGAN TO FEEL VIBRATIONS UNDER HIS FEET WHEN HIS TOES TOUCHED THE SO

  Patient problems: Pain; Shock

  MAUDE report 17002580 ↗
• InjuryMar 9, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS BEEN USING THE BHS DEVICE FOR ABOUT TWO WEEKS WITH THE SFLX 2 COIL. HE SAYS THAT WITHIN THAT TWO WEEK HE HAS TWICE BEEN AWAKENED AT NIGHT WITH A VERY SHARP BURNING PAIN IN HIS GROIN. HE ALSO SAID A COUPLE TIMES HE HAS FELT A SHOCKING SENSATION IN HIS FOOT AND ANKLE. BOTH SENSATIONS ARE ON THE SAME LEG AS THE COIL. HE IS WEARING KINESIOLOGY TAPE AROUND HIS FOOT AND IS WONDERING IF THAT COULD BE CONTRIBUTING. HE SAID HE HAS INSPECTED THE DEVICE AND THERE DOESN'T SEEM TO BE ANYTHING LOOSE OR FAULTY. I ASKED HIM IF HE HAS MADE ANY RECENT CHANGES TO HIS ROUTINE SUCH AS EXERCISE OR STRETCHING AND HE SAID THAT EVERYTHING IS THE EXACT SAME AS TWO WEEKS AGO. THE PATIENT STATED THAT HE GETS A REALLY SHARP PAIN IN HIS GROIN. THIS STARTED ABOUT 2 WEEKS AGO. THE SHOCKING SENSATION AROUND THE LEFT FOOT AND ANKLE AFTER 4 TO 5 DAYS AFTER STARTING USING THE BHS DEVICE AND THE SFLX 2 COIL. THE PATIENT STATED THAT IT IS SIMILAR USING THE TENS UNIT. THE PATIENT STATED THAT SO FAR, HE HAD ABOUT 6 SHOCKING SENSATIONS ON THE LEFT ANKLE AND FOOT THE PATIENT IS FEELING ELECTRIC SHOCKS. THE PATIENT STATED THAT HE ONLY HAS THIS FEELING WHILE USING THE UNIT. THE PATIENT USES TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Pain

  MAUDE report 16516229 ↗
• InjuryMar 3, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT SHE IS EXPERIENCING A BURNING SENSATION INSIDE WHILE USING THE BHS CONTROLLER AND SFLX 2 COIL. THE PATIENT HAS A PROSTHESIS. IT WAS REQUESTED TO SEND THE PATIENT SFLX COIL 1. THE SALES REPRESENTATIVE WILL BE SPEAKING TO THE DOCTOR ABOUT SWITCHING THE PATIENT TO AN ORTHOPAK DEVICE. THE PATIENT STATED THAT SHE HAS A BURNING SENSATION ON THE FRACTURE SITE, AND IT SOMETIMES HURTS. THE PATIENT STATED THAT THE PAIN AND BURNING SENSATION ARE BELOW THE SKIN. THIS STARTED ABOUT A WEEK AGO. THE BURNING AND PAIN STARTED A FEW DAYS AFTER SHE STARTED USING THE DEVICE. THE FRACTURE SITE IS ALSO VERY TENDER AND TINGLES. THE PAIN LEVEL IS AN 8 OUT OF 10 WHILE WEARING THE UNIT. THE PAIN DOES NOT GO AWAY, IT IS CONSTANT. THE PATIENT STATED THAT SHE HAD PAIN BEFORE USING THE STIMULATOR, BUT IT WAS DIFFERENT. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITIES. THE PATIENT HAS NOT STARTED PHYSICAL THERAPY. THE PATIENT SPOKE TO THE NURSE AT THE DOCTOR'S OFFICE. THE NURSE TOLD THE PATIENT TO WEAR THE UNIT FOR ABOUT 4 DURING THE DAY AND 4 HOURS DURING THE AFTERNOON. THE DOCTOR DID NOT PRESCRIBE ANYTHING FOR THE PAIN. THE PATIENT IS NOT TAKING ANYTHING FOR THE PAIN. I TO

  Patient problems: Burn(s); Burning Sensation; Pain

  MAUDE report 16478196 ↗
• InjuryDec 13, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED THAT SHE HAD A LITTLE BIT OF PAIN WHILE USING THE BHS DEVICE LEVEL OF PAIN S UNKNOWN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 15973977 ↗
• InjuryNov 30, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF ENERGY, SLEEPLESSNESS, FEELING WARM IN HER FOOT, AND MAKING HER HEART RACE WITH THE BHS UNIT. THE SALES REPRESENTATIVE INSTRUCTED THE PATIENT TO STOP USING THE UNIT FOR TWO DAYS TO SEE IF THE SYMPTOMS GO AWAY. IF THE PROBLEM RETURNS UPON RESUMING TREATMENT, THE SALES REPRESENTATIVE INDICATED THE PATIENT COULD POTENTIALLY BE SWITCHED TO AN ORTHOPAK. IT WAS REPORTED THAT THE PHYSICIAN HAS REQUESTED THAT THE PATIENT BE SWITCHED TO AN ORTHOPAK. A RETURN LABEL HAS BEEN SENT TO THE PATIENT AND THE OLD PRODUCT WILL BE RETURNED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain; Unspecified Heart Problem

  MAUDE report 15888557 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT IS COMPLAINING OF INTENSE NERVE PAIN AFTER USING THE BHS DEVICE. THE PATIENT ALSO STATED THAT SHE HAS SEVERE FIBROMYALGIA. THE PATIENT WILL BE SWITCHED TO AN ORTHO PAK ASSEMBLY FOR TREATMENT. THE BHS ASSEMBLY AND SFLX 2 COIL WILL BE RETURNED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 15571407 ↗
• InjuryAug 24, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED A SHOCK WHILE TREATING WITH THE BONE HEALING SYSTEM. THE PATIENT STATED THAT THE SFLX 2 COIL IS GIVING HER A SHOCK WHEN SHE WEARS IT. THE PATIENT RATED THE PAIN AS AN 8 ON A SCALE OF 1 TO 10, WHICH IS CONSIDERED SEVERE. THERE ARE NO EXPOSED NOR CRACKED WIRES ON THE COIL. THE DEVICE WAS NOT DROPPED OR IN CONTACT WITH ANY LIQUID. THE PATIENT ADVISED THAT HER ANKLE IS STILL TENDER. THE PATIENT DID NOT SPEAK TO A DOCTOR REGARDING THE ISSUE. THE PATIENT WILL RETURN THE OLD COIL. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 15289332 ↗
• InjuryMar 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT STATED HE HAS A BURNING SENSATION, AND HE ONLY USED THE UNIT FOR A COUPLE OF WEEKS. THE PATIENT STATED HE WORE THE UNIT FOR 1 WEEK. HE WORE THE UNIT FOR 10 HOURS. ONCE HE STARTED TREATMENT, HE WOULD FEEL A NUMBING TINGLING SENSATION SIMILAR TO YOUR FOOT FALLING ASLEEP, FOLLOWED WITH BURNING UNDER THE SKIN. HE WORE A SOCK SO IT WAS NOT ON TOP OF THE SKIN. HE ALSO STATED THAT HE DID NOT KNOW HOW MUCH THE UNIT WOULD COST. THE PATIENT HAD AN APPOINTMENT ON MONDAY (B)(6) 2022, WHERE THE DOCTOR TOLD HIM NOT TO WEAR THE UNIT ANYMORE. THE BHS UNIT WILL BE RETURNED.

  Patient problems: Burning Sensation; Pain

  MAUDE report 13664558 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PULLED THE VELCRO ON HER SFLX 2 COIL SO TIGHT THAT THE COIL BURNED HER FOOT. THE PATIENT THEN TOOK A 3-4 HOUR BREAK FROM TREATMENT, AND THEN TRIED TO TREAT AGAIN AND PULLED THE COIL VERY TIGHT, BUT THE COIL STARTED TO HEAT UP AFTER 15 MINUTES SO SHE STOPPED AND CALLED CUSTOMER SERVICE. THE PATIENT WAS ADVISED THAT SHE SHOULD NEVER PULL THE VELCRO ON THE COIL TOO TIGHT. THE VELCRO SHOULD ONLY BE TIGHT ENOUGH SO THAT IT DOESN'T FALL OFF HER FOOT. THE SALES REPRESENTATIVE WAS CALLED, AND HE SUGGESTED THAT SHE WEAR A SOCK UNDER THE COIL. IF THERE'S AN ISSUE WITH IT FALLING OFF IN BED, SHE CAN LOOSELY WRAP AN ACE BANDAGE OVER THE COIL SO IT DOESN'T FALL OFF HER FOOT DURING THE NIGHT. THE SUGGESTION WAS DISCUSSED WITH THE PATIENT, BUT SHE SAID SHE DOES NOT PLAN TO TREAT IN BED AT THIS TIME. THE PATIENT CLAIMS SHE WILL PAUSE TREATMENT AT NIGHT AND TRY TO TREAT TOMORROW WHILE ADHERING TO SUGGESTIONS. IT WAS LATER REPORTED THAT THE PATIENT'S PAIN WAS ON HER SKIN. THE PATIENT RATED HER PAIN AS A 10 ON A SCALE OF 1 TO 10, WHICH IS CONSIDERED SEVERE. THE PATIENT HAS NOT INCREASED THEIR DAILY ACTIVITIES. THE PATIENT HAS NOT CONTACTED THE DOCTOR, BUT WILL BE DOIN

  Patient problems: Burn(s); Pain

  MAUDE report 12964310 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WHILE USING THE BONE HEALING SYSTEM (BHS). THE PATIENT SAYS THAT HE HAS THROBBING AND PAIN AFTER USING THE BHS FOR JUST 2 HOURS A DAY. THE PATIENT PAIN IS UNDER THE SKIN. THE PATIENT RATED THE PAIN AS A 8 OR 9 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT STATED THE DAY AFTER STARTING TREATMENT THAT HER WOKE UP WITH A HEADACHE THAT LASTED 5 HOURS. THE PATIENT DID REACH OUT TO HER DOCTOR AND RECEIVED A SIGNED SCRIPT FOR THE PATIENT TO SWITCH TO A DIFFERENT DEVICE FOR TREATMENT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 10988184 ↗