Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067717Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00812301020225), received between Jul 19, 2019 and Nov 4, 2024 — classified as 22 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 reports).

4 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAS ISSUES WITH THE ELECTRODES. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THAT BOTH 72R AND 63B ELECTRODES CAUSED AN IRRITATION AND THE 63B WERE THE WORST. SHE USED THE COVER PATCHES WITH THE ELECTRODES AND HAS A SENSITIVITY TO ADHESIVES. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED THE PATIENT TO STOP WEARING THE UNIT AND CONTACT HER DOCTOR AND UPDATE WHAT THEY ADVISED. LATER, AS PER COMPLAINT SPECIALIST, THE PATIENT STATED THAT THEY DEVELOPED RED, ITCHY SKIN WITH TINY BLISTERS AND NO SWELLING WHILE USING THE 72R AND 63B ELECTRODES. THE PATIENT DID NOT CHANGE OR ROTATE THE ELECTRODES FOR 3 DAYS UNTIL THE SKIN IRRITATION GOT WORST. THE PATIENT CONTACTED THEIR PHYSICIAN WHO ADVISED TO STOP WEARING THE UNIT AND PRESCRIBED OTC CREAM AND VITAMIN D SUPPLEMENTS. THE PATIENT ALSO STATED THAT THEY ARE ALLERGIC TO LATEX AND GLUE/ADHESIVES. THE PATIENT STATED THAT THE COVER PATCHES ALSO CAUSED SKIN IRRITATION AND IT RIPPED OFF HER SKIN AS SHE'S ALLERGIC TO ADHESIVES. THE ELECTRODES AND COVER PATCHES MADE THE SKIN IRRITATION WORST ALL TOGETHER. NO FURTHER INFORMATION HAS BEEN REPORTED. THE 63B ELECTRODES HAS NO

  Patient problems: Blister; Rash; Skin Inflammation/ Irritation

  MAUDE report 20598758 ↗
• InjuryOct 31, 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 AND FELT TINGLING SENSATION IN HEEL/ SHIN OF HIS LEGS. THE PATIENT SAID AFTER HE WORE THE STIMULATOR FOR 1-2 DAYS AND 24HRS HE NOTICED A PAIN IN HIS BUTTOCK AND HIGHS. THE PATIENT INDICATED THAT THE PAIN LEVEL WAS AT 9 ON A SCALE OF 1-10, 10 BEING THE WORST. THE PATIENT WAS CONCERNED THAT THIS WAS DUE TO THE STIMULATOR AS AFTER HE REMOVED THE STIMULATOR THE SENSATION IMPROVED AND WENT AWAY AFTER A FEW HOURS. THE SALES REPRESENTATIVE MENTIONED TO THE PATIENT THAT HE MIGHT TRY MOVING THE ELECTRODES A LITTLE WIDER FROM THE INCISIONS AND SEE IF THIS IMPROVES THE SENSATION. ADDITIONALLY, THE SALES REPRESENTATIVE ADVISED THE PATIENT TO CONDUCT THE TIME-TEST. THE PATIENT CONTACTED HIS PHYSICIAN AND SPOKE TO THE PA WHO ADVISED HIM TO CALL (B)(6) MEDICAL. AS PER THE FOLLOW UP CALL, THE PATIENT STATED THAT THEY ARE DOING THE TIME-TEST AS ADVISED BY THE SALES REPRESENTATIVE WHICH SEEMS TO BE HELPFUL AS THE PATIENT IS ONLY EXPERIENCING LITTLE BIT OF TINGLING SENSATION AND HAS NO PAIN AS OF NOW. THEY HAVE TREATED UP TO MAXIMUM OF 2-3 HOURS WHILE DOING THE TIME-TEST. THE PATIENT HAS HIS DOCTOR'S APPOINTMENT ON WEDNESDA

  Patient problems: Pain

  MAUDE report 20577736 ↗
• InjuryJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT FEELS THE ELECTRICAL CURRENT IN HIS HEART AND IT'S MAKING HIM FEEL UNCOMFORTABLE. HE DOES NOT HAVE A PACEMAKER. THE SALES REPRESENTATIVE ADVISED HIM TO STOP USING THE UNIT UNTIL FURTHER NOTICE. NO FURTHER CONSEQUENCES HAS BEEN REPORTED. THE SPINALPAK WAS RETURNED FOR FURTHER EVALUATION.

  Patient problems: Shock

  MAUDE report 19632828 ↗
• InjuryJul 24, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED NECK PAIN FOR 2 WEEKS AND 2 DAYS AFTER USING THE SPINAL PAK DEVICE. THE PATIENT REMOVED THE DEVICE, BUT THE PAIN DID NOT IMPROVE. THE PATIENT WORE THE DEVICE SHE WORE 24 HOURS A DAY. SHE DID NOT CONTACT HER DOCTOR ABOUT THE PAIN, ONLY THE ZIMVIE SALES REPRESENTATIVE. THE PATIENT WAS ADVISED TO CALL THE DOCTOR AND THEN UPDATE US WITH THE LATEST INFORMATION. IF THE DOCTOR SAYS TO CONTINUE, THEN SHE WILL CONDUCT A TIME TEST. SHE TREATED WITH THE DEVICE FOR THREE AND A HALF WEEKS. THE LOWER LEFT SIDE OF MY NECK HURTS. THE PATIENT BELIEVES THAT SHE HAS A STIFF FROM DOING WORK AT HER CHURCH. THE PATIENT STATED THAT THE PAIN LEVEL IS A SIX OUT OF TEN. THE PATIENT STATED THAT THE STIFF NECK IS GETTING BETTER. THE PATIENT SPOKE TO HER DOCTOR WHO TOLD HER TO CONTINUE TREATMENT ONCE THE STIFFNESS GOES AWAY. THE PATIENT STATED THAT SHE DOES NOT BELIEVE THE PAIN IS FROM THE STIMULATOR BUT FROM HER SURGERY. THE PATIENT STATED THAT SHE IS STILL TREATING WITH THE STIMULATOR AND IS STILL HAVING PAIN. THE PATIENT SPOKE TO THE DOCTOR WHO IS AWARE OF THE PAIN AND WANTS THE PATIENT TO KEEP TREATING. THE PATIENT STATED THAT THE DOCTOR DID NOT PRESCRIBE

  Patient problems: Pain

  MAUDE report 17383219 ↗
• InjuryJun 10, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED SHE WAS FEELING PAIN WHEN USING STIM. THE SALES REPRESENTATIVE DIRECTED PATIENT TO DISCONTINUE UNTIL FURTHER INSTRUCTION FROM ZIMVIE. NO PRODUCT TO RETURN, NO REPLACEMENT PRODUCT SENT TO THE PATIENT. IT WAS LATER REPORTED THAT THE PATIENT WAS CALLED REGARDING THE PAIN. THE PATIENT STATED THAT SHE FEELS A PAIN AND A BURNING SENSATION BELOW THE SKIN. THE PATIENT DESCRIBED IT AS A "BONE PAIN." THE PATIENT STATED THAT THE PAIN STARTS ABOUT 4-5 HOURS AFTER STARTING TREATMENT WITH THE UNIT AND SHE DESCRIBED THE PAIN LEVEL AS A NINE OUT OF TEN. THE PATIENT STATED THAT THE PAIN LASTS FOR 10-12 HOURS AFTER SHE STOPS TREATMENT. THE PATIENT SPOKE TO THE DOCTOR AND WAS TOLD TO CONTINUE TREATMENT. NOTHING WAS PRESCRIBED BY THE DOCTOR. THE PATIENT STATED THAT SHE HAS NOT BEEN TREATING AND WILL BE SEEING HER DOCTOR AGAIN IN A FEW WEEKS. NO ADDITIONAL INFORMATION WAS RECEIVED AT THIS TIME. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED. THE SPINAL PAK DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 17102135 ↗
• InjuryDec 20, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT IS COMPLAINING OF PAIN AND NEUROPATHY WHILE USING THE SPINAL PAK ASSEMBLY. THE PATIENT SAID THEY COULD NOT WEAR THE UNIT BEYOND 3 HOURS DUE TO PAIN. THE PATIENT STATED SHE COULDN'T WALK DUE TO PAIN IN HER LEGS. IT WAS LATER REPORTED BY THE PATIENT THAT SHE ONLY USED THE SPINAL PAK FOR 4 DAYS. SHE HAS NERVE DAMAGE IN HER FEET, AND THE DEVICE INCREASED HER PAIN IN HER FEET AND LEGS. BY THE FOURTH DAY, SHE COULD HARDLY WALK. SHE TOOK OFF THE ASSEMBLY, CALLED HER DOCTOR AND THE COMPANY, AND NO LONGER USED IT. THE PATIENT NEVER USED THE DEVICE AGAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Burning Sensation; Pain

  MAUDE report 13049274 ↗
• InjuryMar 22, 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 BY THE SALES REP THAT THE PATIENT STATED THAT THE STIMULATOR HAS REVVED UP ALL OF MY NERVES. PATIENT STATED THAT IT MADE MY BACK, LEGS, AND FEET TINGLY...I COULDN¿T EVEN STAND ON MY FEET IT BOTHERED ME SO MUCH. PATIENT STARTED WEARING THE STIM ON FRIDAY EVENING AND SAID THAT HE DIDN¿T HAVE ISSUES THE INITIAL TWO DAYS, BUT THE PAIN BECAME UNBEARABLE ON SUNDAY. PATIENT STOPPED WEARING THE STIMULATOR ON SUNDAY AND SAID AFTER A COUPLE HOURS HIS PAIN/TINGLING WAS GONE AND IMPROVED. PATIENT HAS NOT RESTARTED WEARING THE STIM. PAIN IS BELOW THE SURFACE OF SKIN, PAIN LEVEL IS 8. ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO WEAR THE UNIT FOR AN HOUR EACH DAY BUT WAS UNABLE TO TOLERATE HOW IT WAS AFFECTING HIS NERVES. THE PATIENT STATED THAT HE CONTINUED TO GET THE PIN PRICK TINGLING FEELING UP AND DOWN HIS LEGS. THE FEELING BECAME INTOLERABLE EVEN BEFORE THE HOUR WAS UP.

  Patient problems: Pain; Paresthesia

  MAUDE report 11543681 ↗
• InjuryMar 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT STATED THAT SHE WAS HAVING PAIN USING THE STIM. SHE STATED THAT SHE HAS MOVED THE ELECTRODES TO DIFFERENT AREAS AND HAS PAIN WHEN IN USE. PATIENT STATED SHE WAS HAVING PAIN USING THE STIM STATES THE PAIN IS BELOW THE SKIN. PATIENT IS TREATING L4-L5 STATES PAIN WAS ABOUT 5 WHEN SHE CHANGES THE 72R ELECTRODES TO NEW POSITION PAIN WENT TO 8 SHE'S NOT SURE IF THE PAIN IS COMING FROM ELECTRODES. STATES PAIN STARTED OUT LITTLE THEN GRADUALLY INCREASED. REPLACEMENT 63B ELECTRODES WERE SHIPPED TO THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. SPINALPAK WAS NOT RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 11398086 ↗
• InjuryJan 25, 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 BY THE SALES REP THAT THE PATIENT THAT WAS GIVEN A SPINAL PAK ON (B)(6) 2020. HIS WIFE CALLED AND SAID HE HAS BEEN HAVING KIDNEY ISSUES SINCE THE SPINAL PAK WAS PLACED. SHE WAS CONCERNED THAT MAYBE THE SPINAL COULD BE CAUSING THIS. UPDATED 12/31, THE PATIENT'S WIFE STATED THAT THE PATIENT STARTED USING THE BONE STIMULATOR ON 12/23. HE STARTED EXPERIENCING ISSUES ON FRIDAY 12/25. SHE STATED THAT THE PAIN WAS SIMILAR TO WHEN HE HAS PAIN FROM KIDNEY STONES. THE PATIENT DOES HAVE A HISTORY OF KIDNEY STONES. THE PAIN WAS IN HIS LOWER BACK WHICH IS WHERE THE PATIENT IS USING THE DEVICE. THE PATIENT STOPPED USING THE DEVICE ON HIS OWN ON 12/25. THEY WERE UNABLE TO SPEAK WITH HIS PRESCRIBING DOCTOR BECAUSE HE WAS OUT OF TOWN. THE PATIENT SAW HIS UROLOGIST ON MONDAY 12/28 AND WAS DIAGNOSED FOR A BLADDER INFECTION. HOWEVER, THE UROLOGIST STATED THE BLADDER INFECTION COULD HAVE BEEN CAUSED BY THE CATHETER FROM THE HOSPITAL. THE PATIENT IS ON MEDICATION FOR BLOOD PRESSURE, CHOLESTEROL AND HIS PROSTATE. THE PATIENT WAS ALSO PRESCRIBED PAIN MEDICATION FOR HIS BACK SURGERY BUT HAS NOT USED IT FOR A WHILE. THE PATIENT HAS DECIDED TO START USING THE DEVICE TOMORROW SINCE HIS BLADDER

  Patient problems: Pain

  MAUDE report 11224433 ↗
• InjuryJan 19, 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 BY THE SALES REP THAT THE PATIENT WAS EXPERIENCING PAIN THROUGHOUT HIS BODY WHILE UTILIZING THE BONE STIMULATOR. HE HAS BEEN WEARING IT 24/7. HE WAS ADVISED TO REMOVE FOR A DAY AND THEN PUT BACK ON FOR A FEW HOUR AT A TIME. STATED HE SAW HIS NEUROSURGEON AND STATED THAT THE UNIT SHOULD NOT CAUSE MUSCLE SPASMS. DOCTOR DID PRESCRIBE MEDS 5PK OF METHOLPREDNISONE FOR THE SPASMS. HE WILL TRY THAT AND SEE WHAT HAPPENS. WILL CALL BACK IF THERE ARE ANY ISSUES. THE PATIENT WAS NOT SENT ANY REPLACEMENT PRODUCTS OR RETURN LABEL.

  Patient problems: Pain

  MAUDE report 11196121 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SHOOTING PAIN DOWN LEG. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WHILE USING THE SPINAL PAK. THE PATIENT DESCRIBED IT AS SHOOTING PAINS DOWN HER LEG BELOW THE SKIN. THE PAIN SUBSIDED WHEN THE PATIENT REMOVED THE SPINAL PAK. THE PATIENT RATED THE PAIN AS A 6 ON A SCALE OF 1 TO 10, WITH 8 OR 9 BEING THE HIGHEST. THE PATIENT STATES THAT SHE HAS NOT INCREASED HER DAILY ACTIVITIES. THE PATIENT ADVISED HER TO TAKE FLEXERIL AND TYLENOL FOR THE PAIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 10872206 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT IS EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 10542025 ↗
• InjuryMay 26, 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 COMPLAINED OF PAIN FROM THE SPINALPAK STIMULATOR. THE PATIENT WAS USING THE DEVICE ON THEIR LUMBAR SPINE. THE PATIENT STATED THAT USING THE SPINALPAK CAUSED HER BACK PAIN TO BECOME WORSE. THE PATIENT REPORTED THAT THE PAIN WAS ON AVERAGE A 5, ON A SCALE OF 1 TO 10. THE PATIENT SAID THAT THE PAIN LEVEL CAN INCREASE UP TO AN 8 OR 9. WHEN THE PATIENT STARTED TO EXPERIENCE MORE PAIN, THE PATIENT DISCONTINUED USE OF THE SPINALPAK STIMULATOR. THE PATIENT REPORTED THAT THE INTENSE PAIN HAS NOT DECREASED SINCE DISCONTINUING TREATMENT WITH THE UNIT. THE PATIENT IS WAITING FOR THE DOCTOR'S OFFICE TO REACH OUT FOR A FOLLOW UP APPOINTMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 10088478 ↗
• InjuryApr 28, 2020Off-Label Use; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH THE SPINALPAK STIMULATOR. THE PATIENT IS USING THE STIMULATOR ON THE CERVICAL REGION OF HER SPINE. THE PATIENT USED THE STIMULATOR FOR TWO DAYS. ON THE FOLLOWING DAY THE PATIENT DID NOT USE THE STIMULATOR AND EXPERIENCED PAIN. THE PATIENT RATED HER PAIN AS AN 8 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT DESCRIBED THE PAIN AS BEING BELOW THE SKIN. THE PATIENT USED THE STIMULATOR THE FOLLOWING DAYS AND EXPERIENCED THE SAME RESULTS. THE PATIENT SAID THAT HER PAIN LEVEL WAS AT A 5 AND SHE WAS USING THE SPINALPAK STIMULATOR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 10004517 ↗
• InjuryApr 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM THE SPINALPAK STIMULATOR. THE PATIENT WAS USING THE SPINALPAK ON HIS LUMBAR SPINE. THE PATIENT SAID THAT THE PAIN STARTED TWO DAYS AFTER HE STARTED TREATMENT WITH THE DEVICE. ON A SCALE OF 1 TO 10 WITH 10 BEING THE WORST, THE PATIENT DESCRIBED THE PAIN AS A 10. THE PATIENT SPOKE TO HIS DOCTOR AND WAS ADVISED TO DISCONTINUE TREATMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 9955360 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NAUSEA WHILE USING THE SPINALPAK STIMULATOR. THE PATIENT STATES THAT WITHIN A HALF HOUR OF USING THE DEVICE, HE EXPERIENCED NAUSEA AND VOMITING. THE SYMPTOMS WOULD LAST ALL DAY. THE PATIENT PLACES THE ELECTRODES JUST BELOW HIS EARS. THE PATIENT REACHED OUT TO HIS SPECIALIST AND WAS PRESCRIBED A MEDICATION FOR THE NAUSEA. THE PATIENT HAS SINCE STOPPED USING THE DEVICE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nausea

  MAUDE report 9900625 ↗
• InjuryMar 3, 2020Off-Label Use; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES FROM USING THE SPINALPAK STIMULATOR. THE PATIENT STATED THAT THE ELECTRODES WERE PLACED ON THE NERVE AND WITHIN THIRTY MINUTES THE HEADACHE BEGAN. THE PATIENT STATED THAT THE PAIN WAS ON THE LEFT SIDE OF THE HEAD. THE PATIENT STATED THAT THE HEADACHE WENT AWAY WITHIN THREE HOURS. THE PATIENT ADVISED THE DOCTOR AND WAS TOLD TO DISCONTINUE USE. THE PATIENT CONTINUED TREATING BUT DESCRIBED THE PAIN AS EXCRUCIATING. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Headache

  MAUDE report 9779637 ↗
• InjuryJan 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM THE SPINALPAK STIMULATOR. THE PATIENT WAS USING THE SPINALPAK STIMULATOR WITH THE LT-4500 AND 72R ELECTRODES. THE PATIENT STATED THAT THE PAIN WAS ON THE RIGHT SIDE OF HER BACK IN THE KIDNEY AREA AND ACROSS THE HIP. THE PATIENT STATED THAT THE PAIN IS BELOW THE SKIN AND THE PAIN LEVEL IS A 10, ON A SCALE OF 1-10. THE PATIENT STOPPED USING THE STIMULATOR AND THE PAIN DID NOT GO AWAY. THE PATIENT CALLED THEIR DOCTOR AND WAS PRESCRIBED IBUPROFEN AND ADVISED NOT TO USE THE STIMULATOR FOR A WEEK. THE PATIENT BELIEVES THAT THE PAIN WAS FROM THE INFLAMMATION OF THE INCISION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 9627139 ↗
• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM USING THE SPINALPAK STIMULATOR. THE PAIN STARTED A WEEK AFTER USING THE UNIT. THE PAIN IS ON THE LUMBAR AREA GOING DOWN TO THE BUTTOCKS AND THE PAIN IS BELOW THE SKIN. THE PATIENT STATED THAT SHE FEELS LIKE SHE IS CARRYING EXTRA WEIGHT. THE PATIENT SAYS THAT THE PAIN LEVEL IS AT A 10. THE PATIENT STOPPED HER PHYSICAL THERAPY AS IT WAS CAUSING HER PAIN. THE PATIENT WENT TO HER PAIN MANAGEMENT DOCTOR AND WAS PRESCRIBED MEDICATION. THE PATIENT WAS PREVIOUSLY ON THIS MEDICATION BUT WAS EASING OFF OF IT. THE PATIENT SAW HER SURGEON AND WAS TOLD TO CONTINUE USE OF THE SPINALPAK STIMULATOR AND WAS PRESCRIBED PAIN MEDICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 9459692 ↗
• InjuryOct 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SPINALPAK STIMULATOR WAS CAUSING THE PATIENT'S HEART RATE TO INCREASE. THE PATIENT STATED THAT HIS HEART RATE INCREASED TO OVER 100 AND WOULD ONLY REACH THAT LEVEL WHEN HE WAS WEARING THE SPINALPAK STIMULATOR. HE REACHED OUT TO HIS CARDIOLOGIST AND THE ORDERING DOCTOR TO DISCUSS HIS SYMPTOMS AND BOTH ADVISED HIM TO STOP USING THE UNIT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9218004 ↗
• InjuryOct 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPINALPAK STIMULATOR DISTURBED THE PATIENT'S HEART CONDITION. THE PATIENT APPLIED THE UNIT FOR TWO HOURS AND STATED THAT HER HEART BEGAN TO BEAT VERY FAST. THE PATIENT TOOK THE UNIT OFF AND CALLED HER DOCTOR WHO ADVISED THE PATIENT TO TAKE THE UNIT OFF IMMEDIATELY AND RETURN IT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9165677 ↗
• InjuryJul 19, 2019Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BLOOD CLOTS FROM USING SPINALPAK. PATIENT STATED TO HAVE USED UNIT FOR 3 DAYS AND THEN WAS ADMITTED TO HOSPITAL FOR BLOOD CLOTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Thrombus

  MAUDE report 8807317 ↗

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-1617-2024 · Mar 22, 2024 · Open, Classified
  Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bon
• 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