CMF SpinalogicRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912011495), received between Jul 25, 2016 and Apr 14, 2020 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT "HAS METAL BEADS FROM HER LYNX PROCEDURE AND USED HER SPINALOGIC STIM ONCE AND FELT A PAINFUL PULL." IT WAS THEN CLARIFIED THAT THE PATIENT "DID NOT HAVE ANY PERMANENT DAMAGE FROM THE USE OF THE DEVICE AND THE USE OF THE DEVICE WAS DISCONTINUED IMMEDIATELY BUT THAT THERE MAY HAVE BEEN POSSIBLE PERMANENT DAMAGE TO THE PATIENT IF THE USE OF THE DEVICE WAS CONTINUED."

  Patient problems: Increased Sensitivity

  MAUDE report 9957500 ↗
• MalfunctionMar 27, 2020Fluid/Blood Leak; Battery Problem; Fluid/Blood Leak; Battery Problem

  IT WAS REPORTED THAT THE PATIENT "USED THE DEVICE SINCE THE BEGINNING OF JANUARY AND WHEN SHE TRIED IT TODAY SHE HEARD A POPPING SOUND AND NOW THE BATTERY IS LEAKING." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9891706 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT "BEGAN PRODUCING (KIDNEY) STONES. THEY WERE SO BAD HE HAD TO HAVE CYSTO, LITHOTRIPSY AND A STINT. [SIC] HE THEN GOT A DVT (DEEP VEIN THROMBOSIS)." THE PATIENT "HAS TO HAVE MORE TREATMENTS FOR A STONE GROWING IN THE OTHER KIDNEY SINCE BOTH KIDNEY COULD NOT BE TREATED AT THE SAME TIME. [SIC] PATIENT'S WIFE "FEELS IT CAUSED HIM TO HAVE 18 KIDNEY STONES." THE PATIENT HAS DISCONTINUED USE OF THE DEVICE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 9774032 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING LOSS OF VISION AFTER TREATMENTS WITH HER SPINALOGIC BONE GROWTH STIMULATOR. IT IS UNKNOWN WHETHER THE LOSS OF VISION IS PERMANENT OR TEMPORARY. FURTHER INFORMATION HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN PROVIDED.

  Patient problems: Loss of Vision

  MAUDE report 9259387 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S "LOWER LEGS STARTED SWELLING. THEY HAD TO TAKE HIM TO THE EMERGENCY ROOM. THEY GAVE HIM A STEROID SHOT AND THE SWELLING WENT DOWN. HE USED HIS BONE STIM AND THE SWELLING CAME RIGHT BACK." THE PATIENT PREVIOUSLY HAD A "LOW BACK FUSION" AND HAD BEEN USING THE BONE STIMULATOR FOR THREE WEEKS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Swelling

  MAUDE report 9093321 ↗
• MalfunctionJun 13, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT WAS SITTING IN A CHAIR USING HER SPINALOGIC AND SHE FELT SOMETHING WARM. SHE STOOD UP AND IMMEDIATELY REMOVED THE DEVICE. SHE TOOK OFF THE DEVICE AND IT HAD BURNED TWO HOLES INTO TWO OF HER SHIRTS, A T-SHIRT AND A BLOUSE. THERE WAS REPORTEDLY NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697774 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT USAGE OF THE DEVICE DURING TREATMENT ALTERED THE PATIENT'S HEART RATE. AT THE 1ST TREATMENT, AFTER ABOUT THREE MINUTES, HER HEART SKIPPED A BEAT AND STARTED POUNDING. SHE TOOK OFF THE DEVICE AND HER RAPID HEARTBEAT LASTED ABOUT THIRTY MINUTES. WHEN SHE TRIED HER SECOND TREATMENT, SHE FELT LIKE PINS AND NEEDLES WERE STABBING HER. THE PATIENT WAS ADVISED TO STOP ANY USE OF THE DEVICE IMMEDIATELY AND CALL HER PHYSICIAN. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO DISCONTINUE USE. THE PATIENT HAS HAD A DOUBLE BYPASS AND STENTS WERE PUT IN. SHE ALSO HAS A WIRE AROUND HER STERNUM.

  Patient problems: Non specific EKG/ECG Changes; Pain

  MAUDE report 8582060 ↗
• InjuryJul 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT RECEIVED THAT ALLEGES "WHEN 1ST GOT THE DEVICE THERE WAS NO ISSUES USING IT, BUT ON (B)(6) 2018 SHE GOT A SHOCK WHILE USING THE DEVICE & WAS IN PAIN. SAID SHE HAS GONE TO THE EMERGENCY ROOM (ER) & WAS INFORMED THAT SHE HAS TITANIUM RODS IMPLANTED & SO THE MAGNETIC WAVES WAS CAUSING THE SHOCKS TO HER BODY. SAID SHE ALSO TALKED TO HER DR & DR HAS INFORMED HER TO STOP USING THE DEVICE. PATIENT STATES HAS NOT USED THE DEVICE SINCE (B)(6) 2018 BUT IS STILL GETTING SHOCKS INSIDE HER BODY".

  Patient problems: Electric Shock

  MAUDE report 7690879 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUS VOLUNTARY EVENT REPORT: MW5072830 I HAD 2 LEVEL LUMBAR SURGERY L4-S1 ON (B)(6) 2017. I WAS TOLD BY THE NEUROSURGEON TO USE THIS DEVICE FOR 2 MONTHS TO HELP WITH THE FUSION/BONE GROWTH PROCESS. I STARTED ON (B)(6) 2017 AND STOPPED AFTER 40 DAYS OF DAILY USE. THE DEVICE AUTOMATICALLY SHUTS OFF AFTER 30 MINUTES AND ALLOWS ONLY DAILY USE. IT IS PROGRAMMED. THE DEVICE COVERED ALL OF MY LUMBAR AND THORACIC SPINE AREAS. SLOWLY OVER THIS TIME, I NOTICED A LOT OF WEAKNESS/PAIN IN THE BONES ESPECIALLY THE SACRUM, HIPS, T-SPINE AND RIBS, NECK AND DOWN TO THE ANKLE JOINTS. AROUND THE ANKLE JOINT, I FEEL I WOULD FRACTURE THE BONE. I ALSO FACED EXTREME FATIGUE DURING THE TIME I USED THIS DEVICE. IT IS MY BELIEF THAT IT WORSENED OR WEAKENED AREAS OF MY SPINE I.E. NECK AND THORACIC SPINE WHICH ALREADY HAVE DEGENERATIVE DISC DISEASE/ARTHRITIS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7059234 ↗
• InjuryJul 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT RECEIVED THAT ALLEGES CALLED TO TELL US THAT HE WAS DIAGNOSED WITH RENAL FAILURE AND WANTED TO KNOW IF IT WAS THE RESULT OF THE BONE STIMULATOR. WE ASKED HIM IF HE HAD SPOKEN WITH HIS DOCTOR AND HE TOLD US NO". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

  Patient problems: Renal Failure

  MAUDE report 5819004 ↗