Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00812301020232), received between Dec 2, 2019 and Jun 16, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (P850022); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 22, 2024Class IIOpen, Classified

   Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

   Z-1617-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED DISCOMFORT DURING TREATMENT WITH THE DEVICE. THE PATIENT STATED THAT TOWARDS THE END OF THE NIGHT, THE LEFT ANKLE HURTS. THE PATIENT MANAGES THE PAIN BY TREATING WITH THE DEVICE EVERY OTHER DAY. THE PATIENT SPOKE WITH HER DOCTOR WHO SAID IT WAS OKAY TO TREAT EVERY OTHER DAY; HER DOCTOR DID NOT PRESCRIBE ANYTHING FOR THE PAIN. THE PATIENT STATES THAT WHEN SHE USES THE UNIT, SHE EXPERIENCES PAIN, AND THE PAIN LEVEL IS A 4. IF THE PATIENT USES THE UNIT FOR TWO DAYS IN A ROW, THE PAIN LEVEL IS AT A 10. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25520272 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP ADVISED THAT THE PATIENT'S ANKLE HAS BEEN IN A LOT OF PAIN SINCE WEARING THE UNIT. THE PATIENT WAS CALLED AND ADVISED THAT SHE USED THE UNIT FOR 24 HOURS AND WAS IN MORE PAIN AFTER USING THE UNIT. THE PATIENT WAS IN PAIN BEFORE USING THE UNIT. THE PATIENT STOPPED USING THE UNIT AND CALLED THE DOCTOR, SHE'S WAITING FOR A CALL BACK. THE PATIENT WAS ADVISED TO TAKE A TIME TEST. NO RETURN NOTED. UPDATE 12/15/25: THE PATIENT WAS CALLED AND HER PAIN LEVEL WAS A 10.

  Patient problems: Pain

  MAUDE report 23982516 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING STABBING, SHARP PAIN WHEN SHE TREATS WITH THE ORTHOPAK.THE PATIENT WAS ADVISED TO REMOVE THE ELECTRODES AND ONLY USE THE UNIT FROM 30 MINUTES TO 2 HOURS. THE DOCTOR SUBMITTED A NEW RX FOR THE PATIENT TO SWITCH TO A BHS DEVICE TO SEE IF THE PATIENT CAN TOLERATE THIS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 23597308 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DURING TREATMENT WITH THE ORTHOPAK. THE PATIENT WAS SWITCHED TO THE BONE HEALING SYSTEM (BHS). IT WAS LATER REPORTED THAT THE PATIENT ATTEMPTED TO USE THE ORTHOPAK FOR ABOUT A WEEK. NO FURTHER INFORMATION COULD BE PROVIDED REGARDING HOW LONG THE PATIENT WAS ABLE TO TREAT WITH THE DEVICE BEFORE THE PAIN STARTED. NO FURTHER CONSEQUENCES ARE REPORTED. THE ORTHOPAK WAS RECEIVED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23568616 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEY EXPERIENCED SHOOTING PAINS WHILE TREATING WITH THE BONE STIMULATOR. PATIENT STATED HE WAS TREATING HIS RIGHT BIG TOE WHEN HE WAS SLEEPING AND THEN ONCE WHEN HE WAS AWAKE. BOTH TIMES HE EXPERIENCED SHARP SHOOTING PAINS ON THE OUTSIDE OF HIS RIGHT THIGH EVERY COUPLE OF SECONDS. THE PAIN WAS CONSTANT UNTIL HE STOPPED TREATMENT. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23404232 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING THROBBING PAIN WHILE USING THE ORTHOPAK DEVICE. THE PATIENT HAD BEEN WEARING THE DEVICE 24 HOURS PER DAY SINCE (B)(6) 2025 AND THE PAIN STARTED ON (B)(6) 2025. THE PATIENT DID NOT DO ANY EXTRA ACTIVITIES. THE PATIENT RATED THE PAIN AS AN 8 OR 9 ON A SCALE OF 1-10. THE PATIENT IS TAKING TYLENOL AND AWAITING A CALL BACK FROM THEIR DOCTOR. CUSTOMER SERVICE ADVISED THE PATIENT TO REMOVE THE DEVICE FOR A FEW DAYS. IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO TREAT FOR 8 TO 10 HOURS PER DAY AND HER PAIN LEVEL REMAINED AT AN 8 OR 9 OUT OF 10. THE PATIENT IS UNABLE TO PINPOINT WHEN THE PAIN STARTS SINCE IT COMES AND GOES. THE PAIN IS IN THE LEFT SHOULDER WHERE THE FRACTURE IS. THE PATIENT STATED THAT SHE HAS A FOLLOW UP APPOINTMENT WITH HER ORTHOPEDIC DOCTOR ON (B)(6) 2025. THE PATIENT WANTS TO CONTINUE TREATING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21677161 ↗
• InjuryDec 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WHILE USING THE ORTHOPAK. IT WAS LATER REPORTED THAT THE PATIENT HAS PAIN WHILE WALKING. EVERY TIME THE PATIENT MOVES HIS ARM IT HURTS. THE PAIN STARTED AFTER USING THE ORTHOPAK. THE PAIN IS AT THE FRACTURE SITE AND THE PATIENT RATED THE PAIN A 10 OUT OF 10. THE PATIENT DID NOT SPEAK TO HIS DOCTOR. THE PATIENT IS TAKING IBUPROFEN 600 MILLIGRAMS BUT IT DOES NOT HELP. THE PATIENT STOPPED USING THE DEVICE (B)(6) 2024, BUT THE PAIN DID NOT SUBSIDE AT ALL. THE PATIENT WAS ADVISED BY CUSTOMER SERVICE TO CONTACT THE DOCTOR AND TO TAKE A BREAK FROM TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20989486 ↗
• InjuryNov 11, 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 HAD NAUSEA, HEADACHES, AND BODY TINGLING. THE PATIENT SPOKE WITH THEIR ORTHOPEDIC SURGEON WHO REPORTEDLY STATED THAT HE HAD HEARD OF PATIENTS HAVING THESE SYMPTOMS. THE PATIENT WAS ADVISED BY HER PHYSICIAN TO DISCONTINUE USE AS THERE WAS NO BONE GROWTH AFTER USING THE STIMULATOR FOR 2 MONTHS. THE PATIENT WAS USING THE DEVICE ON HER LEFT FOOT. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE ORTHOPAK ASSEMBLY WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Headache; Nausea; Paresthesia

  MAUDE report 20657251 ↗
• InjurySep 16, 2024Adverse 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 BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN WHILE USING ORTHOPAK UNIT. LATER, THE PATIENT WAS CONTACTED AGAIN FOR ADDITIONAL INFORMATION AND STATED THAT THEY HAVE BEEN WEARING THE DEVICE FOR TOO LONG AND INDICATED THAT THE PAIN WAS AT 10 ON A SCALE OF 1-10. THE PATIENT CONTACTED THEIR PHYSICIAN BUT, THE CAUSE OF THE PAIN WAS NOT IDENTIFIED, AND DOCTOR DID NOT PRESCRIBE ANY MEDICATIONS. THE PATIENT DECIDED TO CONDUCT A TIME-TEST AS ADVISED BY THE SALES REPRESENTATIVE AND STATED THAT THE PAIN SUBSIDED WITH SHORTER TREATMENT TIME. NO FURTHER INFORMATION HAS BEEN REPORTED. THE ORTHOPAK UNIT HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 20224390 ↗
• InjuryMay 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED A CRAMP IN HER FOOT WHILE TREATING WITH THE ORTHOPAK DEVICE. THE PATIENT IS TREATING HER BIG TOE. THE PATIENT RATED THE PAIN LEVEL AN 8 OUT OF 10, 10 BEING THE HIGHEST. USUALLY WHEN SHE TURNS THE DEVICE OFF THE CRAMPS DISAPPEAR. THE PATIENT STATED THAT THIS DISCOMFORT BEGAN ABOUT ONE WEEK AFTER SHE STARTED TREATING. AND HAS BEEN HAPPENING FOR ABOUT ONE MONTH OF TREATMENTS. THE PATIENT SPOKE WITH HER FOOT DOCTOR, WHO SUGGESTED THAT SHE CONTACT US AND HAD NO OTHER ADVICE. THE PATIENT STATED THAT SHE EXPERIENCED PAIN FROM HER FOOT TO THE CALF WHILE DRIVING AND WAS NOT TREATING WITH THE DEVICE. THE LAST TIME SHE TREATED BEFORE TODAY'S DISCOMFORT WAS YESTERDAY BEFORE BEDTIME. THE PATIENT WAS ADVISED TO PAUSE TREATMENT UNTIL SHE HAD NO DISCOMFORT. SHE CAN PERFORM THE TIME TEST AND BEGIN THE TEST AT 30 MINUTES PER DAY FOR THREE DAYS IF SHE IS COMFORTABLE, THEN ADD 30 MINUTES EVERY 3 DAYS. THE PATIENT AGREED TO CALL BACK WITH ANY ISSUES. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19397908 ↗
• InjuryMay 1, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS HAVING HEADACHES WHEN USING ORTHO PAK., NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF TODAY.

  Patient problems: Headache

  MAUDE report 19222580 ↗
• InjuryDec 12, 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 HAS EXPERIENCED 2 MIGRAINES SINCE HE STARTED USING THE ORTHO PAK DEVICE THE PATIENT IS USING THE ORTHOPAK ON HIS FOOT BUT WAS WONDERING IF THE STIMULATOR COULD BE TO BLAME. THE PATIENT STOPPED USING THE STIMULATOR ON SATURDAY. THE PATIENT ALSO MENTIONED THAT HE HAS COMPLEX REGIONAL PAIN SYNDROME. THE PATIENT SPOKE WITH HIS DOCTOR AND THE DOCTOR CALLED THE ZIMVIE SALES REPRESENTATIVE. THE PATIENT IS TAKING IBUPROFEN/TYLENOL FOR PAIN. THE PATIENT WAS ADVISED TO CONDUCT A TIME TEST AT ONE-HOUR INCREMENTS AFTER THE PAIN SUBSIDES. THE PATIENT WILL CALL BACK WITH AN UPDATE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Headache; Pain

  MAUDE report 18310144 ↗
• InjuryNov 29, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT REPORT THAT HE FELT A BURNING SENSATION ON HIS SKIN WHILE TREATING WITH THE ORTHOPAK DEVICE. THE PATIENT STATED THAT HE FOUND A HUGE BURN ON THE SKIN. THE PATIENT SPOKE TO HIS FOOT DOCTOR AND PRIMARY CARE PHYSICIAN. THE PRIMARY CARE PHYSICIAN ADVISED THE PATIENT TO USE AN ANTIBIOTIC OINTMENT. THE PATIENT STATED THAT HE CONTACTED THE ZIMVIE SALES REPRESENTATIVE WHO ADVISED HIM TO USE THE 48" LEAD WIRE AND TO KEEP THE CONTROLLER IN HIS PANTS POCKET INSTEAD OF THE SOCK. THE PATIENT'S SKIN WAS RED, SWOLLEN AND IT HAD A BLISTER. THE SKIN ISSUE WAS THE SHAPE OF THE CONTROLLER FROM WEARING IT AGAINST HIS SKIN. THE PATIENT¿S ATTORNEY IS IN POSSESSION OF THE DEVICE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 18231968 ↗
• InjuryNov 29, 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 THAT HE HAS A METAL ROD IN THE FEMUR. THE PAIN INCREASES WHEN HE USED THE DEVICE, THEN DECREASES WHEN HE STOPS TREATING WITH THE DEVICE. THE PATIENT CONTACTED THE DOCTOR¿S OFFICE AND LEFT A MESSAGE WITH ASSISTANT. THE PATIENT DID NOT SPEAK TO THE DOCTOR ONLY WITH THE ZIMVIE SALES REPRESENTATIVE. THE PATIENT WORE THE DEVICE 24/7. THE PATIENT WILL STOP WEARING THE DEVICE AND CONDUCT TIMED TEST. HE WILL CALL BACK IF ANY ISSUES. THE PATIENT LATER REPORTED THAT THE PAIN IS BELOW THE SKIN. THE PATIENT RATED THE PAIN LEVEL AS AN 8 ON A SCALE FROM 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT HAS NOT BEEN ABLE TO GET IN TOUCH WITH HIS DOCTOR BUT DOES HAVE AN APPOINTMENT ON DECEMBER 20TH. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Limb Pain; Pain

  MAUDE report 18231434 ↗
• InjuryAug 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH THE ORTHO PAK DEVICE. THE PATIENT DOES NOT FEEL PAIN WHILE USING THE STIMULATOR. THE PATIENT FEELS A LITTLE MORE PAIN THAN USUAL THE DAY AFTER THE TREATMENT, BUT SHE IS NOT SURE WHETHER THE PAIN IS FROM THE UNIT OR FROM PHYSICAL THERAPY. THE LAST X-RAY THAT WAS TAKEN LAST WEEK HAD SHOWN BONE HEALING. THE PAIN IS BELOW THE SKIN. THE PATIENT TOLD HER THE DOCTOR ABOUT THE PAIN AND WAS ADVISED TO CONTINUE USING THE DEVICE. THE PATIENT STATED THAT HER RIGHT ARM IS BROKEN, AND SHE IS HAVING A HARD TIME PUTTING THE UNIT ON. THE PATIENT RATED THE PAIN AS A 4 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT HAS INCREASED HER DAILY ACTIVITY. THE PATIENT IS HAVING PHYSICAL THERAPY. THE DOCTOR IS HAPPY THAT SHE HAS THE DEVICE. THE DOCTOR PRESCRIBED HYDROCODONE WITH ACETAMINOPHEN. THE PATIENT SOMETIMES TAKES THE PRESCRIBED MEDICATION OR WILL TAKE TYLENOL OVER THE COUNTER. THE PATIENT MENTIONED SHE HAD A SKIN RASH FOR ABOUT A WEEK BUT THEN IT WENT AWAY. HOWEVER, THE PATIENT DID NOT WANT TO SPEAK ABOUT THE RASH. THE PATIENT WAS NOT SENT A REPLACEMENT PRODUCT. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 17652190 ↗
• InjuryJun 10, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT HE WANTED TO RETURN THE DEVICE BECAUSE HE EXPERIENCED PAIN AND WAS NOT USING IT. THE PATIENT SAID THE 1ST DOCTOR WHO PRESCRIBED THE DEVICE SCREWED UP AND PUT THE WRONG ROD IN AND THE BONE WAS RUBBING WHICH CAUSED THE PAIN. THE PATIENT HAD TO GO SEE ANOTHER DOCTOR WHO DID HIS TOTAL KNEE REPLACEMENT. THAT DOCTOR PERFORMED THE CORRECTIVE SURGERY AND DID NOT TELL HIM HE HAD TO USE THE DEVICE. EVERYTHING IS HEALING FINE NOW.

  Patient problems: Pain

  MAUDE report 17102131 ↗
• InjuryMay 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE WITH HIS ORTHOPAK DEVICE. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT, AND HE DID NOT HAVE TIME TO TALK, AND COMMITTED TO CALLING BACK WITH THE DETAILS. THE PATIENT REPORTED THAT THE DEVICE CAUSED HIS BONE TO GROW WHERE THE BONE WAS NOT SUPPOSED TO GROW. THE PATIENT WAS DISAPPOINTED IN OUR PRODUCT. THE PATIENT HAS HAD AN INJURY TO HIS COLLARBONE. HE WAS USING THE ORTHOPAK TO GROW BONE AND AVOID SURGERY. WHEN HE HAD A FOLLOW UP VISIT WITH HIS DOCTOR, THE X-RAY SHOWED THAT HIS BONE DID NOT HEAL AND THERE WAS "BONE GROWTH IN PLACES WHERE IT SHOULD NOT HAVE GROWN. THE PATIENT WENT ON TO STATE THAT THE TREATMENT WAS NOT EFFECTIVE BECAUSE HE NEEDED SURGERY. THE PATIENT'S DOCTOR TOLD HIM TO DISCONTINUE TREATMENT PRIOR TO HIS SURGERY AS TREATMENT WAS MEANT TO BE A PREVENTATIVE PLAN TO AVOID SURGERY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Extraskeletal ossification

  MAUDE report 16956941 ↗
• InjuryDec 2, 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 HE HAS A LOT OF PAIN WHILE USING THE ORTHOPAK ON THE LEFT SHOULDER. THE PATIENT STATED THAT THE PAIN STARTED WITHIN AN HOUR OF USING THE ORTHOPAK AND IS IS BELOW THE SKIN. ACCORDING TO THE PATIENT, THE PAIN IS RADIATING TO THE NECK AND DOWN THE ARM. THE PATIENT REPORTED THAT THE PAIN LEVEL IS AN 8 OUT OF 10. THE PATIENT HAS NOT INCREASED HIS DAILY ACTIVITIES. THE PATIENT STATED HE CALLED THE DOCTOR SPOKE TO THE PA WHO TOLD THE PATIENT TO CONTACT OUR COMPANY. THE PATIENT REPORTED THAT THE DOCTOR DID NOT PRESCRIBE ANYTHING, BUT HE IS TAKING ADVIL FOR THE PAIN. THE PATIENT REPORTED THAT HE REMOVED THE ORTHOPAK ABOUT 3 HOURS AGO AND THE PAIN IS SUBSIDING VERY SLOWLY. ANA MARIA LEPIANI TOLD THE PATIENT TO WAIT A COUPLE OF DAYS THEN START USING THE UNIT DOING THE TIME TEST. THE PATIENT WAS ASKED TO PLEASE GIVE US A CALL BACK ON THE 3RD OR 4TH DAY TO LET US KNOW HOW HE IS FEELING. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 15902363 ↗
• InjuryJan 27, 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 SALES REP THAT THE PATIENT'S SKIN HAS IRRITATION ON THE LEFT FOOT. THE SKIN IRRITATION STARTED ABOUT A WEEK AND HALF AGO. THE PATIENT IS USING THE 72R ELECTRODES. THE SKIN IS VERY RED WITH BLISTERS. IT IS STRICTLY UNDER THE ELECTRODES. THE ELECTRODES ARE CHANGED EVERY 2 DAYS, AND THE ELECTRODES ARE NOT ROTATED. THE AREA IS CLEAN WITH SOAP AND WATER. NO WIPES. THE PATIENT DOES NOT HAVE SENSITIVE SKIN. NO NEW PRODUCT. NO ALLERGIES. THE PATIENT TAKES BLOOD PRESSURE MEDICATION. THE PATIENT WENT TO SEE HIS DOCTOR WHO TOLD HIM TO STOP USING THE BONE GROWTH STIMULATOR. NO PRESCRIPTION. 72R ELECTRODES LOT # 115901. 63B ELECTRODES AND USPS POUCH WAS SHIPPED TO THE PATIENT. A RETURN POUCH HAS BEEN SENT TO THE PATIENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13367880 ↗
• InjuryDec 20, 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 IS EXPERIENCING PAIN WITHIN THE TREATMENT SITE AFTER WEARING THE DEVICE. SHE HAS STOPPED USING THE DEVICE UNTIL THE PAIN IMPROVES. THE PATIENT STATED THAT THE PAIN IS ON THE LEFT FEMUR. THE PATIENT WAS HAVING PAIN AT A 1 OUT OF 10 WITH MEDICATION AND 5 OUT OF 10 WITHOUT MEDICATION. THE PATIENT HAS BEEN RECEIVING PHYSICAL THERAPY TO HELP HER IMPROVE HER MOBILITY AND BALANCE (USING HER WALKER) BUT HAD TO STOP BECAUSE SHE COULD NOT HANDLE THE PAIN AND DISCOMFORT. IT WAS LATER REPORTED THAT THE PATIENT USES TRAMADOL, GABAPENTIN AND TYLENOL AS PRESCRIBED BY THE DOCTOR. IT WAS STATED THAT THE DOCTOR RECOMMENDED THE PATIENT CONTINUE TREATING FOR 4 TO 8 HOURS A DAY INSTEAD OF 24 HOURS A DAY. THE PATIENT IS USING THE PRODUCT FOR 1 TO 3 HOURS A DAY INSTEAD OF THE HOURS RECOMMENDED BY THE DOCTOR DEPENDING ON THE DISCOMFORT SHE FEELS. THE PATIENT FEELS PAIN WITH OR WITHOUT USING THE UNIT BUT WHEN SHE IS USING IT HER DISCOMFORT SEEMS TO BE MORE.

  Patient problems: Pain

  MAUDE report 13049302 ↗
• InjuryNov 15, 2021Patient-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 BY THE SALES REP THAT THE PATIENT STARTED FEELING AN ACHING PAIN IN HER MUSCLES. SHE THOUGHT IT MAY BE FROM THE OPAK, SO SHE STOPPED USE, AND THE PAIN SUBSIDED. SHE THEN STARTED USING THE OPAK AGAIN, AND THE PAIN RETURNED AFTER TREATING FOR 4 DAYS. THE PATIENT WAS ADVISED TO STOP USE AGAIN. THE PATIENT'S DOCTOR ADVISED THEM TO TAKE A COUPLE OF DAYS OFF TO TAKE A BREAK. SHE WAS ADVISED TO CUT HER TIME IN HALF AND WEAR THE UNIT EVERY OTHER DAY TO SEE IF THAT HELPS. THE PATIENT HAS NOT HAD MUSCLE PAIN SINCE.

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

  MAUDE report 12816718 ↗
• InjuryAug 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP. ((B)(4)) "I HAVE A QUESTION ON THE BONE STIMULATOR ON (B)(6). AFTER USING IT, SHE EXPERIENCED SOME PAIN AND SWELLING. DR. (B)(6) WAS WONDERING IF THE DEVICE ITSELF HAS ANY VIBRATION TO IT WHICH MAY HAVE CAUSED THE PAIN SINCE THE FRACTURE IS DISPLACED? ". THE ORTHOPAK DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12384366 ↗
• InjuryAug 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP WHO STATES THE PATIENT IS HAVING SOME TIGHTNESS AND DISCOMFORT WHILE USING HER ORTHOPAK FOR HER HIP. PATIENT STATED THAT SHE IS HAVING SOME TIGHTNESS AND DISCOMFORT WHILE USING UNIT. PATIENT STATES PAIN STARTED SAME DAY SHE RECEIVED UNIT STATES MUSCLES IN HER LEG WAS TIGHT AND PAIN GO INTO HER INNER THIGH. PATIENT STATES PAIN LEVEL IS 10. PATIENT STATES SHE DID NOT SEEK MEDICAL TREATMENT AND TAKING PERCOCET¿S AND MUSCLES RELAXER. SHE STATES SHE WILL BE SEEING HER DOCTOR TUESDAY AND WILL CALL BACK WITH UPDATE. ADVISED HER TO CONDUCT A TIME TEST AT ONE-HOUR INCREMENTS AFTER HER PAIN SUBSIDES. TREAT 1 HOUR PER DAY FOR THE FIRST THREE DAYS. IF SHE DOES NOT EXPERIENCE ANY PAIN, SHE SHOULD INCREASE TREATMENT TIME BY 1 HOUR EACH DAY AFTER THAT. ADVISED HER TO CALL BACK WITH ANY ISSUE DURING THE TIME TEST.

  Patient problems: Discomfort; Pain

  MAUDE report 12365651 ↗
• InjuryAug 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THEY SPOKE WITH THE DAUGHTER AND PATIENT HAS PAIN WHILE IT IS ON. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. ORTHOPAK WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 12267703 ↗
• InjuryJul 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT IS COMPLAINING OF NEUROPATHY PAIN USING HER STIMULATOR. SHE DID STOP USING IT FOR 3 DAYS AND FELT BETTER, WHEN SHE PUT THE STIMULATOR BACK ON YESTERDAY, THE PAIN RETURNED. UPDATE 6/22: SAID SHE IS FEELING GREAT AND NO LONGER HAS ANY PAIN OR DISCOMFORT.

  Patient problems: Pain

  MAUDE report 12161103 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P850022. One submission often covers many models, so check the product and lot details in each record.

• Z-1619-2024 · Mar 22, 2024 · Open, Classified
  48" Lead Wires, Replacement Part Number: 1067724-4
• Z-1618-2024 · Mar 22, 2024 · Open, Classified
  20" Lead Wires, Replacement Part Number: 1067724-2
• Z-1616-2024 · Mar 22, 2024 · Open, Classified
  Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat