Biomet SpinalPak Non-invasive Spine Fusion Stimulator SystemRecalls & reported problems across all models

We found 2 models of Biomet SpinalPak Non-invasive Spine Fusion Stimulator System by Ebi, LLC in the FDA's device registry (GUDID). Together they are named in 284 adverse event reports in the FDA's MAUDE database, received between May 1, 2019 and Sep 29, 2026 — classified as 1 death, 283 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (117 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Biomet SpinalPak Non-invasive Spine Fusion Stimulator System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1616-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Biomet SpinalPak Non-invasive Spine Fusion Stimulator System problems

Biomet SpinalPak Non-invasive Spine Fusion Stimulator System models

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

• Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716

  Stimulator, Bone Growth, Non-Invasive
  1 recall1 death262 reports
• Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067717

  Stimulator, Bone Growth, Non-Invasive
  22 reports

Recent Biomet SpinalPak Non-invasive Spine Fusion Stimulator System adverse event reports

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

• InjurySep 29, 2026Patient-Device Incompatibility

  Patient problems: Pain

  MAUDE report 50934222 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50790521 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was in pain. Attempts have been made to obtain additional information; however, no further information has been provided.

  Patient problems: Pain

  MAUDE report 50754219 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing pain while wearing the bone growth stimulator. The patient conducted a time test but this did not help.It was later reported that the first time the patient used the unit the patient had to remove the device due to throbbing pain. The pain level was rated a 10 out of 10. The patient did not increase daily activities. The patient was taking Dilaudid and Cyclobenzaprine for the pain. The patient attempted the time test at 1 hour per day and still had pain. The patient was advised by the doctor to stop using the device due to pain. No further consequences were reported.

  Patient problems: Pain

  MAUDE report 50754161 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50724874 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had pain on his leg at the time of the fitting for the stimulator. The patient also had low blood sugar through the night and was not feeling well. The patient also stated that he is having back pain in the surgical area and his right leg will not work. The sales representative advised the patient to stop using the stimulator. The sales representative later spoke with the doctor¿s office who advised that the patient had been having pain prior to the surgery and had issues with numbness in his leg. This is not a new issue. The nurse stated that the patient had not called the doctor¿s office for pain medicine. It was also noted that the patient is listed as a diabetic. No further information was provided.

  Patient problems: Numbness; Pain

  MAUDE report 50275165 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED THAT THE PATIENT IS EXPERIENCING ISSUES WHILE USING THE UNIT. THE PATIENT SPOKE WITH CUSTOMER SERVICE AND STATED THAT SHE SUFFERS FROM A PRE-EXISTING CONDITION, SEVERE RESTLESS LEG SYNDROME. THE PATIENT EXPERIENCED AN EXACERBATION OF THESE SYMPTOMS WHEN SHE STARTED TREATMENT WITH THE UNIT. THE PATIENT STATED IT WAS VERY UNCOMFORTABLE; SHE GOT NO SLEEP AND WAS IN PAIN. THE PAIN LEVEL WAS 4 OUT OF 10. THE PATIENT SPOKE WITH HER SURGEON'S OFFICE, AND THEY SUGGESTED SHE CONSULT WITH HER NEUROLOGIST. THE NEUROLOGIST ADVISED THE PATIENT TO DISCONTINUE THE SPAK TREATMENT AS THE BENEFITS DO NOT OUTWEIGH THE SYMPTOMS SHE IS EXPERIENCING. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25665573 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE EXPERIENCED PAIN WHILE TREATING WITH THE DEVICE. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25462190 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED THAT THE PATIENT EXPERIENCED A BURNING PAIN IN HER BUTTOCKS AFTER SLEEPING WITH THE DEVICE LAST WEEKEND. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THAT THE PADS HAD BURNED HER ON HER BACK. THE PATIENT STATED SHE HAD PAIN IN HER BUTTOCKS. THE 72R ELECTRODES WERE CLOSE TO EACH OTHER, 3 INCHES APART. THE PATIENT STATED SHE HAS 2 RED MARKS ON HER BACK. SHE HAD THE ELECTRODES ON FOR 2 OR 3 DAYS WHEN SHE GOT THE BURN ON (B)(6). THE PATIENT STATED SHE HAS PAIN ON HER BUTTOCKS. THE PATIENT WENT TO HER PCP TODAY AND GOT AN INJECTION FOR THE PAIN. THE PATIENT STATED THE PAIN HAS GONE AWAY. THE PATIENT DID NOT CALL THE SURGEON. THE PATIENT HAS INCREASED HER DAILY ACTIVITIES. HER FOOT STARTED SWELLING. THE PAIN LEVEL FROM THE BURN WAS A 10. THE PATIENT ASKED HER HUSBAND TO TAKE THE ELECTRODES OFF. THE PAIN IN THE BUTTOCKS WAS A 10 AS WELL. THE PATIENT STATED THAT SHE DID NOT HAVE THIS PAIN BEFORE. THE PATIENT CANNOT SLEEP BECAUSE OF THE PAIN. THE PATIENT DOES NOT WANT TO CONTINUE TREATMENT. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 25414848 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT SHE EXPERIENCED PAIN DURING TREATMENT. THE PATIENT STATED THAT SHE USED THE UNIT FOR 1 TO 2 HOURS AND HAD TRIED TO USE THE UNIT 3 TIMES TO TREAT, AND THEN SPOKE WITH HER DOCTOR. THE DOCTOR STATED THAT SHE DOES NOT NEED TO USE IT, AS SHE IS HEALING WITHOUT IT. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 25396003 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED THAT THE PATIENT EXPERIENCED PAIN DURING TREATMENT. THE PATIENT WORE THE DEVICE FROM HIS APPOINTMENT FITTING AND TOOK IT OFF AT 11PM; THERE WAS NO PAIN. THE PATIENT STATED THAT HE WOKE UP AT 1:30 AM IN SEVERE PAIN AND ALMOST WANTED TO GO TO THE EMERGENCY ROOM. THE PATIENT SAID THE PAIN WAS WHERE THE FUSION WAS AND POSSIBLY RADIATING DOWN HIS LEGS. THIS MORNING, THE PAIN HAS SUBSIDED AND IS NEAR NORMAL FOR SURGICAL HEALING PAIN. THE PATIENT STATED HE DID NOT TURN ON HIS MEDTRONIC PAIN STIMULATOR LAST NIGHT OR WHILE WEARING THE SPINAL PAK DEVICE. NO REPLACEMENT PRODUCT WAS SHIPPED. IT WAS LATER REPORTED THAT CUSTOMER SERVICE RECEIVED A CALL BACK FROM THE PATIENT, WHO STATED HE HAD PUT THE STIMULATOR ON YESTERDAY. HE STATED THE STIMULATOR CAUSED SIGNIFICANT, CONSTANT PAIN AND THAT THE PAIN KEPT HIM UP ALL NIGHT. THE PATIENT RATED THE PAIN LEVEL AT A 9. THE PATIENT DID NOT CALL THE DOCTOR. THE PATIENT ADVISED THAT THE SALES REP WOULD CONTACT HIS DOCTOR. THE PATIENT SAID THAT HE TOOK TRAMADOL AND TYLENOL FOR THE PAIN. THE PATIENT CALLED BACK AGAIN. CUSTOMER SERVICE EXPLAINED THAT ALL INFORMATION REGARDING THE DISCOMFORT HAD BEEN COLLECTED. THE PATIENT EXPLAINED HE

  Patient problems: Pain

  MAUDE report 25240909 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  PER CS REP (B)(6), RECEIVED EMAIL FROM SALES REP, (B)(6). SUBJECT: PATIENT COMPLAINT (B)(4). HELLO, I RECEIVED THIS TEXT MESSAGE FROM THIS PATIENT OVER THE WEEKEND AND I CALLED HER BACK ON SATURDAY BUT DID NOT REACH HER AND JUST LEFT A VOICEMAIL. I JUST TRIED HER AGAIN TONIGHT AND SPOKE TO HER AND I TOLD HER THAT SOMEBODY FROM CUSTOMER SERVICE WOULD GIVE HER A CALL, BUT THAT THEY'RE PROBABLY GOING TO TRY AND RECOMMEND SHE START USING IT FOR JUST AN HOUR OR TWO A DAY AND THEN SLOWLY BUILD UP. SHE SAID THAT SHE EXPERIENCED SOME SPASM PAIN IN HER RIGHT HIP ALONG WITH SOME EDEMA. SHE TOOK IT OFF ON SATURDAY AND HASN'T PUT IT ON SINCE AND SHE ALSO HAS LOST SOME STRENGTH IN HER RIGHT LOWER EXTREMITY. IF SOMEBODY FROM CUSTOMER SERVICE, COULD PLEASE CALL HER ON WEDNESDAY TO DISCUSS THAT WOULD BE GREAT. (B)(6) THIS IS (B)(6). THE BONE GROWTH STIMULATOR CAUSED PAIN AND LOSS OF STRENGTH IN MY RIGHT LEG. FINALLY TOOK IT OFF LAST EVENING UNTIL I CAN TALK TO YOU. (B)(6). I CALLED THE PATIENT REGARDING PAIN AND LOSS OF STRENGTH IN THE RIGHT LEG. THE PATIENT STATED THAT THE STIMULATOR CAUSED PAIN ON THE RIGHT HIP AND SWELLING. THE PATIENT TOOK OFF THE UNIT AND SHE STARTED FEELING BETTER. THE PATIE

  Patient problems: Pain

  MAUDE report 25123373 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE TREATING WITH THE SPINALPAK. THE PATIENT WORE THE DEVICE FOR 2 TO 3 HOURS. THE PATIENT RATED THE DISCOMFORT LEVEL AT A 2 OUT OF 10, WITH 10 BEING THE HIGHEST. THEN, AT NIGHT IN BED, THE PATIENT EXPERIENCED WORSE PAIN AT A 7 OR 8 OUT OF 10. THE PATIENT CONTINUED TREATMENT WITH THIS DISCOMFORT FOR ABOUT ONE WEEK. THEN THE PATIENT TOOK A BREAK FROM TREATMENT AND THE PAIN SUBSIDED. AT THIS POINT THE PATIENT CHOSE TO DISCONTINUE TREATMENT. THE PATIENT DID NOT DISCUSS THE PAIN WITH THEIR DOCTOR. THE PATIENT HAD NOT INCREASED THEIR ACTIVITY LEVEL. THE PATIENT REPORTED THE PAIN WAS BENEATH THE SURFACE OF THE SKIN AND FELT LIKE IT WAS IN THEIR BONES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 25093523 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT SHE HAS BEEN HAVING LOWER BACK PAIN. THE PATIENT STATED THAT SHE HAD THE SURGERY 6 AND A HALF MONTHS AGO. WHILE USING THE SPINALPAK UNIT CONSISTENTLY, THE PAIN IS A LEVEL 7. IF THE PATIENT DOES NOT USE THE SPINALPAK UNIT, THE PAIN GOES TO 4. ONCE THE SPINALPAK UNIT IS TAKEN OFF, IT TAKES ABOUT 2 DAYS FOR THE PAIN TO DISSIPATE A LITTLE BIT. THE PATIENT'S DOCTOR IS AWARE OF THIS. THE DOCTOR DOES NOT KNOW WHY SHE IS HAVING THIS PAIN AND WAS TOLD TO SPEAK TO HER PHYSICAL THERAPIST. THE PATIENT ALSO USES A TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION) UNIT BUT NOT AT THE SAME TIME. THE PATIENT FEELS LIKE IT IS MUSCLE PAIN IN HER LOWER BACK. THE DOCTOR PRESCRIBED MELOXICAM AND CELEBREX FOR THE PAIN, BUT IT DID NOT WORK. THE PATIENT HAS SLOWLY INCREASED HER DAILY ACTIVITY. THE PATIENT STATED THAT THE PAIN INTENSIFIES THE MORE DAYS SHE USES THE SPINALPAK UNIT. THEN THE PATIENT STOPS USING THE SPINALPAK STIMULATOR TO USE THE TENS UNIT, AND AFTER A FEW DAYS, THE PAIN GOES DOWN, AND THEY START THE PROCESS AGAIN OF USING THE SPINALPAK STIMULATOR. THE PATIENT WAS ADVISED TO STOP USING THE SPINALPAK DEVICE FOR A FEW DAYS, THEN START THE TIME TEST AND CALL US BACK W

  Patient problems: Pain

  MAUDE report 24886390 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the SpinalPak device burned the patient's leg when it was in her pocket. The unit was not hot to the touch and there was no mark on her leg. The patient advised that it was an internal burning pain. The patient noted her right leg was still sore the day after the incident. The pain level was rated an 8 out of 10. The patient called her doctor who advised the patient to stop using the unit for a week. No further consequences were reported.

  Patient problems: Pain; Skin Burning Sensation

  MAUDE report 24651901 ↗

Other Ebi, LLC products

• Biomet SpinalPak / OrthoPak8 models · 362 reports · 2 recalls
• Biomet EBI Bone Healing System12 models · 327 reports
• Biomet OrthoPak Non-invasive Bone Growth Stimulator System2 models · 42 reports · 1 recall