Biomet EBI Bone Healing System 1068229Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00812301020546), received between Jul 24, 2020 and May 20, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SWELLING. THE PATIENT ADVISED THAT THEY HAD ALWAYS HAD THE DISCOMFORT AND SWELLING, BUT LATELY IT HAD BEEN WORSE. THE PATIENT STATED THAT THEIR USUAL DISCOMFORT WAS RATED 6 OUT OF 10, AND WHEN PUTTING WEIGHT ON THE FOOT THE DISCOMFORT IS AN 8 OUT OF 10. THE PATIENT STATED THAT SOME DAYS THEY DID NOT TREAT WITH THE BONE HEALING SYSTEM DEVICE AT ALL BECAUSE THE SFLX 3 COIL PUTS PRESSURE ON THEIR SWOLLEN TENDON. THE PATIENT NOTED THAT THEIR LEVEL OF ACTIVITY HAD NOT CHANGED RECENTLY BUT STATED THAT THEY BEGAN PUTTING WEIGHT ON THEIR FOOT APPROXIMATELY 3 WEEKS AGO. THE PATIENT BEGAN TAKING APPROXIMATELY 10 STEPS PER DAY, THEN RETURNING TO THE WHEELCHAIR. THE PATIENT¿S DOCTOR REQUESTED THAT THE PATIENT BE SWITCHED TO ANOTHER BONE GROWTH STIMULATOR AS THE PATIENT HAD NOT HAD ANY BONE GROWTH. AN ORTHOPAK DEVICE WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 25230637 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PAIN WHEN WEARING THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24024135 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHE WAS IN A LOT OF PAIN WHILE TREATING. THE PATIENT STATED THAT SHE WORE THE UNIT FOR 5 HOURS. THEN TOOK A BREAK FOR A FEW HOURS. THEN WORE IT AGAIN FOR 90 MINUTES AND BEGAN FEELING PAIN. THE PATIENT DID NOT TELL THE DOCTOR, ONLY THE SALES REP. THE PATIENT WILL CONDUCT THE TIME TEST AND CALL BACK WITH ANY ISSUES. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURN FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23961422 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED PAIN WHILE TREATING. PATIENT SPOKE TO THE SALES REPRESENTATIVE AND HER DOCTOR WHO SUGGESTED THE TIME TEST AND EXPLAINED THE TIME TEST. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23279515 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE IS IN A LOT OF PAIN WHILE TREATING AND SOME HEAT. THE SALES REP SUGGESTED TIME TEST, THE PATIENT WILL START WITH 1 HOUR FOR 2 DAYS AND THEN INCREASE. CUSTOMER SERVICE CALLED THE PATIENT REGARDING THE PAIN AND HEAT. THE PATIENT SAID SHE WAS AT WORK AND REQUEST A CALL BACK AT ANOTHER TIME. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 22730852 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S FOOT WAS VERY SWOLLEN AND NUMB. INITIALLY THERE WAS NO PAIN. THE PATIENT STATED THAT THEY HAD NOT DONE ANY EXTRA ACTIVITIES. THE PATIENT ALSO STATED THAT THE FIRST DAY HE PUT ON THE UNIT, HE HAD ON A PAIR OF PAINTS WITH 6 ZIPPERS, CLIPS, AND METAL CHAINS. WHEN HE TOOK OFF HIS PANTS THE PINS AND NEEDLES WENT AWAY. IT WAS LATER REPORTED THAT THE PATIENT SPOKE WITH THEIR DOCTOR WHO ADVISED TO EXPECT SOME SWELLING AND PAIN BUT TO CONTINUE TREATING. THE PATIENT STATED THE SWELLING HAD SUBSIDED BUT WAS NOW EXPERIENCING SOME PAIN. THE PATIENT WANTED TO CONTINUE TREATING BECAUSE THE DOCTOR SAID TO EXPECT PAIN. NO FURTHER INFORMATION WAS PROVIDED. IT WAS LATER REPORTED THAT THE PATIENT'S DOCTOR TOLD HIM TO KEEP USING THE DEVICE EVEN THOUGH HE FEELS AN ELECTRICITY-LIKE FEELING RUNNING THROUGH HIS BODY EVEN WHEN THE DEVICE IS OFF. THE PATIENT STATED THAT HE SOUGHT A SECOND OPINION AND THAT THE DOCTOR TOLD HIM HIS SURGERY IS ALL WRONG AND HE WOULD NEED ANOTHER SURGERY TO CORRECT IT. THE PATIENT HAS NOT USED THE DEVICE SINCE THE INITIAL COMPLAINT AND DOES NOT PLAN TO RESUME TREATMENT IN THE FUTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21314496 ↗
• InjuryFeb 14, 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 BY THE PATIENT THAT AFTER AN HOUR OF WEAR TIME, THE BHS CAUSES EXTREME PAIN, AND SHE CAN ONLY WEAR IT FOR AN HOUR AT A TIME. THE ORTHOPEDIC DOCTOR TOLD HER TO CUT BACK TO LIKE 3 HOURS A DAY OR BREAK UP INTO SESSIONS. THE PATIENT SAW THE RHEUMATOID DOCTOR AND HE TOLD HER THE SETTING COULD BE ADJUSTED AND TO CALL. THE PATIENT WAS UPSET AT THE HASSLE. THE PATIENT WAS TOLD BY THE SALES REPRESENTATIVE THEY WOULD REACH OUT TO A TEAM MEMBER. THE SALES REPRESENTATIVE WANTED TO CHECK IF THE BHS COULD BE SWITCHED TO AN OPAK DEVICE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.IT WAS LATER REPORTED BY THE PATIENT THAT WHEN SHE WEARS THE UNIT, THE PAIN IS IN HER LEFT HAND. THE PATIENT IS HAVING PAIN WITHIN AN HOUR TO TWO HOURS. THE PATIENT IS TREATING THE FOREARM. THE PATIENT STATED THAT SHE COMPARES THE PAIN TO NERVE PAIN OR CARPAL TUNNEL PAIN. THE PAIN LEVEL STARTED AT A 2 OR 3 OUT OF 10 AND IT WOULD BUILD UP AND AFTER A FEW HOURS, THE PATIENT WILL TAKE IT OFF. THE PATIENT TREATS WITH THE DEVICE APPROXIMATELY 5 HOURS A DAY. THE PATIENT HAS SEEN HER SURGEON. THE PATIENT TAKES OFF THE UNIT WHEN THE PAIN LEVEL IS AT AN 8.

  Patient problems: Pain

  MAUDE report 18707909 ↗
• InjuryOct 27, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT NOT NEAR HER FRACTURE SITE AND THE PAIN WAS PRESENT WHEN SHE WAS NOT USING HER BHS DEVICE. BECAUSE THE REPORTED CONDITION REQUIRED MEDICAL INTERVENTION (THE LEVEL OF PAIN IS NOT INDICATED), IT IS CONSIDERED A SERIOUS INJURY. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 18025191 ↗
• 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 17002650 ↗
• InjuryMay 25, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE TREATING WITH THE BHS DEVICE (COIL). THE PATIENT STATED THAT THE PAIN STARTED ABOUT A WEEK AGO. THE PAIN IS DEEP KIND OF LIKE BONE PAIN. THE PAIN IS NOT CONSTANT. PAIN LEVEL IS A 5. THE PATIENT HAS NOT FELT ANY PAIN SINCE SHE STOPPED USING THE UNIT. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITIES. THE PATIENT CONTACTED THE NURSE AT THE DOCTOR'S OFFICE. THE NURSE TOLD HER TO USE THE STIMULATOR FOR LESS THAN 10 HOURS AND TO SPEAK TO THE SALES REPRESENTATIVE. THE DOCTOR DID NOT PRESCRIBE ANYTHING. THE PATIENT TOOK TYLENOL. THE SWELLING WAS ON TOP OF THE FOOT. THE PATIENT STATED THAT WHEN SHE USED THE STIMULATOR HER FOOT WAS SWOLLEN AS BAD AS T WAS RIGHT AFTER THE SURGERY. HER TOES FELT WEIRD LIKE THEY WERE GOING NUMB. THE PATIENT STOPPED USING THE BHS YESTERDAY AND TODAY THE FOOT IS NOT SWOLLEN. THE PATIENT STOPPED USING THE UNIT YESTERDAY PER THE SALES REPRESENTATIVE. THE COIL WAS NOT TOO TIGHT. THE SALES REPRESENTATIVE TOLD THE PATIENT THAT THERE WAS A DIFFERENT UNIT THAT THE PATIENT COULD TRY BUT SHE WOULD HAVE TO SPEAK TO THE DOCTOR. THE PATIENT HAS NOT FELT ANY PAIN SINCE SHE STOPPED USING THE UNIT. THE PATIENT HAS NOT IN

  Patient problems: Numbness; Pain; Swelling/ Edema

  MAUDE report 17002630 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE BHS UNIT IS MAKING HER ANKLE "PAINFULLY ACHY". THE PATIENT STOPPED USING THE STIMULATOR YESTERDAY AND SAID SHE HAD SOME CONTINUED ACHINESS. HOWEVER, IT WAS NOTHING IN COMPARISON TO WHEN SHE WORE HER STIMULATOR. ACCORDING TO THE SALES REPRESENTATIVE, THE PATIENT HAS DISCONTINUED USE AT THIS POINT. THE PATIENT REPORTED THAT THE PAIN STARTED AFTER 2 OR 3 HOURS OF USING THE STIMULATOR. THE PATIENT STATED THAT SHE STARTED GETTING AN ACHING SENSATION AND IT GOT WORSE AND WORSE. THE PATIENT DESCRIBED IT AS "A PAINFUL ACHING FEELING". THE PATIENT STATED THAT SHE IS USING THE UNIT ON THE LEFT FIBULA NEAR THE ANKLE. THE PATIENT STATED THAT THE PAIN LEVEL IS AT 8 OR 9 OUT OF TEN AND THAT SHE CANNOT WALK IF SHE KEEPS THE UNIT ON IF IT IS MORE 3 TO 4 HOURS. THE PATIENT REPORTED THAT THE PAIN IS BELOW THE SKIN AND STARTS TO SUBSIDE AFTER 3 OR 4 HOURS. THE PATIENT WENT ON TO STATE THAT THE ANKLE STARTS SWELLING AFTER 3 OR 4 HOURS AND THAT THE LONGER SHE WEARS THE UNIT THE MORE PAINFUL IT GETS. THE PATIENT STATED THAT SHE HAS NOT INCREASED HER DAILY ACTIVITIES. THE PATIENT REPORTED THAT SHE LEFT A MESSAGE WITH THE NURSE A FEW HOURS AGO AND SHE HAS A

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15982718 ↗
• InjuryNov 23, 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 THAT THE PATIENT CHANGED TO A SMALLER COIL AFTER THE CAST/SPLINT WAS REMOVED AND NOW HAS PINS AND NEEDLES WHEN HE USES THE BHS DEVICE. THE PATIENT STATED THAT HE HAS NUMBNESS AND SOMETIMES PINS AND NEEDLES IN HIS TOES WHILE TREATING WITH THE BHS UNIT. THE PATIENT STATED HE INITIALLY USED THE SFLX 2 COIL WHILE IN HIS CAST FOR SEVERAL WEEKS WITH NO ISSUES. AFTER THE CAST REMOVAL, THE PATIENT STATED THAT HE HAS BEEN USING THE SFLX 3 COIL AND HAD BEEN EXPERIENCING DISCOMFORT SINCE (B)(6). THE PATIENT STATED THAT HE HAD NUMBNESS AND TINGLES EVERY NIGHT BUT EACH DAY SEEMS TO GET BETTER AND HE WAS ONLY NUMB FOR APPROXIMATELY 90 MINUTES. THE PATIENT REPORTED THAT HE TREATS AT THE ANKLE AND FEELS DISCOMFORT IN HIS TOES. THE PATIENT FURTHER STATED THAT HE FEELS NUMBNESS UNDER THE SKIN AND DOES NOT DESCRIBE THE DISCOMFORT AS PAIN. THE PATIENT WAS ADVISED TO CALL HIS DOCTOR AND HE WILL CONTINUE WITH TREATMENT AT THIS TIME AS HE STATED THE ISSUE WITH THE SENSATION IS IMPROVING WITH TIME. THE PATIENT ALSO STATED THAT HE THINKS THE ISSUE COULD BE BECAUSE OF THE POSITION HE SLEEPS IN. THE PATIENT REPORTED THAT THE PAIN LEVEL FROM THE COILS IS A 3 OUT OF 10, BUT SOMETIMES CAN GET UP

  Patient problems: Numbness; Pain

  MAUDE report 15851318 ↗
• InjuryMar 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 SAID SHE FEELS PAIN. THE ZIMMER BIOMET SALES REPRESENTATIVE RECOMMENDED THE WEAR THE STIM FOR 2 HOURS TODAY AND TOMORROW, THEN 3 HOURS FOR THE 2 DAYS AFTER, AND INCREASE AN HOUR EVERY 2 DAYS. THE SALES REPRESENTATIVE TOLD THE PATIENT THAT SHE WOULD REPORT THE PAIN COMPLAINT, AND SOMEONE MIGHT REACH OUT TO HER. THE PATIENT STATED THAT SHE WEARS THE SLFX 3 COIL ON HER FIBULA. THE PATIENT REPORTED THAT THE PAIN IS BELOW THE SKIN. THE PATIENT STATED THAT THE PAIN FEELS THE SAME AS WHEN HER FIBULA BONE WAS GRAFTED. THE PAIN THAT SHE EXPERIENCED HAS REACHED AS HIGH AS A 10 ON A SCALE OF 1 TO 20 BUT IS USUALLY AT A 7. THE PATIENT ALSO STATED THAT HER LEG HAS BEEN SWELLING BUT SHE WILL TRY USING THE UNIT LATER TODAY. THE PATIENT SPOKE TO THE DOCTOR ABOUT THE PAIN, AND HE STATED THAT THE PAIN WAS TO BE EXPECTED AND SHE HAS NOT BEEN PRESCRIBED ANYTHING. HE PATIENT HAS NOT RECENTLY INCREASED THEIR DAILY ACTIVITIES NOR TAKEN ANY OVER-THE-COUNTER MEDICATION FOR THE PAIN. ZIMMER BIOMET RECOMMENDED THAT THE PATIENT CONTACT HER DOCTOR ABOUT THE SWELLING BEFORE USING THE UNIT AGAIN AND EXPLAINED THE TIME TEST TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATI

  Patient problems: Pain

  MAUDE report 13722939 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT IS HAVING AN INCREASED AMOUNT OF ACHING AND STIFFNESS IN HER ANKLE SINCE SHE STARTED TREATMENT WITH THE BHS. ALSO, THE PATIENT WAS EXPERIENCING A LOT OF HEADACHES, WHICH WERE NOT NORMAL FOR HER. SHE WONDERS IF IT IS RELATED TO THE BONE STIMULATOR. ACCORDING TO HER, SHE'S BEEN TRAVELING RECENTLY, SO THE HEADACHES MAY BE RELATED. AS A RESULT OF THE PATIENT'S ACHING AND HEADACHES, THE SALES REPRESENTATIVE ASKED IF THE DOCTOR'S OFFICE WOULD LIKE HER TO TRY THE ORTHO PAK. THE PATIENT AGREED AND SAID SHE WOULD ALSO CONSULT WITH HER DOCTOR. THE PATIENT STATED THAT SHE WORE THE UNIT FOR 8-10 HOURS AT NIGHT WITH NO MEDICATION. SHE IS SEEING A PHYSICIAN ON THURSDAY FOR A FOLLOW-UP VISIT. SHE STATED THAT THE HEADACHES COULD BE RANDOM, BUT HER FOOT WAS STIFF AND ACHY, AND SHE WAS LIMPING MORE AFTER WEARING THE UNIT. THE PATIENT WAS ADVISED TO CUT BACK TO A FEW HOURS TO SEE IF THAT HELPS, AND SHE WILL CALL BACK WITH AN UPDATE. IT WAS LATER REPORTED THAT THE DOCTOR HAS REQUESTED TO SWITCH THE PATIENT TO THE ORTHO PAK DUE TO HER BHS COMPLAINTS. AN RX WAS PROVIDED. AN ORTHO PAK ASSEMBLY HAS BEEN SENT TO THE PATIENT, AND THE BHS WILL BE RETURNED. IT WAS REPORTED THA

  Patient problems: Headache; Pain

  MAUDE report 13046391 ↗
• InjuryMar 16, 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 WAS EXPERIENCING BAD CRAMPS IN HER FOOT WHILE USING THE BONE HEALING SYSTEM (BHS). THE PATIENT RECEIVED THE DEVICE ON (B)(6) 2021. THE PATIENT SAYS THAT THE PAIN STATED ABOUT 2 DAYS INTO TREATING WITH THE BHS. THE PATIENT RATED THE PAIN AS AN 8 OR 9 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PAIN WAS BELOW THE SURFACE OF THE SKIN. THE PAIN DOES NOT SUBSIDE WHEN THE PATIENT IS NOT TREATING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 11499093 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT REPORTS THAT SHE FEELS SPASMS IN HER FOOT ABOUT 30-45 MINUTES AFTER USE. SHE DID ADVISE WHEN SHE FEELS THIS, SHE TAKES THE DEVICE OFF AND IT STOPS, THEN CONTINUES TREATMENT. THE PATIENT STATED THAT THE SPASMS STARTED THE FIRST TIME SHE USED THE BHS AND WITHIN 15 MINUTES THE PATIENT STATED THAT SHE HAD PAIN AND THE FOOT JUMPED. IT IS LIKE A THROBBING ACHING PAIN. THE PAIN DIMINISHES AFTER 6 HOURS OF USING THE STIMULATOR. THE PAIN LEVEL IS 8 TO 9. THE PAIN IS BELOW THE SKIN DEEP INSIDE. THE PATIENT DOES NOT HAVE PAIN WHEN SHE IS NOT TREATING. THE PATIENT HAS INCREASED HER DAILY ACTIVITY BUT NOW SHE HAS SLOWED DOWN. THE PATIENT DID SPEAK TO HER PHYSICIAN. THE DOCTOR TOLD HER THAT IT WAS PROBABLY BECAUSE SHE WAS ON HER FEET TOO LONG. THE PATIENT STATED THAT IT IS A DIFFERENT PAIN WHEN SHE IS ON HER FEET THEN WHEN SHE IS USING THE STIMULATOR. THE DOCTOR PRESCRIBED ANTIBIOTICS AND PERCOCET. I TOLD THE PATIENT TO DO THE TIME TEST. INCREASE EVERY DAY BY AN HOUR AND TO KEEPS US POSTED ON THE PROGRESS. THE PATIENT WEARS THE COIL OVER A SOCK AND ACE BANDAGE.

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

  MAUDE report 11177840 ↗
• InjuryDec 18, 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 EXCRUCIATING PAIN FROM THE BONE HEALING SYSTEM (BHS). THE PATIENT STATED THAT HE USED THE DEVICE FOR THE FIRST DAY AND WITH IN MINUTES HE HAD EXCRUCIATING PAIN. THE PATIENT RATED THE PAIN LEVEL AS A 10 ON A SCALE FROM 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT SAYS THAT THE PAIN SUBSIDES WITHIN AN HOUR. THE PATIENT TOOK IBUPROFEN 800 MG. THE PATIENT STATED THAT HE USED IT THE NEXT DAY WITH THE SAME RESULTS. HE BELIEVES THAT THE UNIT IS NOT HELPING HIM AND HE IS VERY GRATEFUL BUT HE DOES NOT WANT. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 11041968 ↗
• InjuryNov 24, 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 HAS NOT BEEN ABLE TO USE THE DEVICE WITHOUT IT CAUSING HER PAIN. THE DOCTOR WANTED THE PATIENT TO SWITCH TO A DIFFERENT DEVICE FOR TREATMENT AND REQUESTED TO CONVERT HER TO AN ORTHOPAK DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 10898172 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND SWELLING FROM THE BONE HEALING SYSTEM (BHS). THE PATIENT WAS TREATING A PROXIMAL ULNAR FRACTURE NONUNION WITH THE BHS. THE PATIENT REPORTED THAT SHE USED THE DEVICE FOR 3 DAYS. THE PATIENT STATED THAT THE PAIN AND SWELLING WOULD START AFTER 2 OR 3 HOURS OF TREATING WITH THE DEVICE. THE PATIENT'S RIGHT ARM WOULD SWELL FROM THE ELBOW DOWN. THE PATIENT DESCRIBED THE PAIN AS INSIDE THE BONE AND ON A SCALE OF 1 TO 10, THE PATIENT RATED THE PAIN AS A 7 OR 8. THE PATIENT STATED THAT IT TOOK ABOUT A WEEK FOR THE SWELLING TO GO AWAY. THE PAIN WAS STILL PRESENT AFTER A WEEK. THE PATIENT REPORTED THAT SHE RECENTLY INCREASED HER DAILY ACTIVITIES. THE PATIENT WENT TO SEE HER DOCTOR WHO ADVISED THE PATIENT TO GIVE THE BHS ANOTHER TRY. THE PATIENT TRIED TO WEAR THE DEVICE AGAIN AND WITHIN 6 OR 7 HOURS, HER ARM WAS SWOLLEN AND IN A LOT OF PAIN. THE PATIENT CONTACTED HER DOCTOR AND THE DOCTOR TOLD THE PATIENT TO DISCONTINUE USE. THE DOCTOR PRESCRIBED OXYCODONE FOR THE PAIN. THE PATIENT REPORTED THAT THE PAIN AND SWELLING WENT AWAY AFTER A WEEK OR TWO. THE PATIENT STILL HAS RESIDUAL PAIN. THE PATIENT IS NO LONGER USING THE DEVICE. IT WAS REP

  Patient problems: Pain; Swelling

  MAUDE report 10352973 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SLIGHT BURNING SENSATION WHILE USING THE BONE HEALING SYSTEM (BHS). THE PATIENT WAS USING THE DEVICE TO TREAT A MID-PATELLAR DELAYED UNION. THE PATIENT SCHEDULED AN APPOINTMENT WITH HER DOCTOR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burning Sensation

  MAUDE report 10321523 ↗