SpF®-PLUS-Mini (60 uA/M) 10-1398MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00812301020126), received between May 1, 2019 and Nov 5, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (P850035); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AFTER TRIPPING AND FALLING. THE FIRST FEW DAYS AFTER THE FALL THE PATIENT EXPERIENCED PAIN AND HAD BRUISES TO THE HANDS, WRISTS, AND KNEES. THREE TO FIVE DAYS AFTER THE FALL, THE PATIENT¿S SYMPTOMS SPIKED. THE PATIENT EXPERIENCED A PARALYZING EFFECT ON EVERYTHING FROM THE TORSO DOWN THROUGH THE LEGS. THE PATIENT¿S HAND-EYE COORDINATION WAS OFF, AND THE PATIENT HAD ZERO BALANCE. THE PATIENT STATED THAT THEY HAD NEVER EXPERIENCED ANYTHING SO PAINFUL. THE PATIENT WAS LATER HOSPITALIZED FOR A SEPTIC INFECTION THAT THEY FEEL THE SPINAL STIMULATOR COULD HAVE CONTRIBUTED TO. THE PATIENT IS UNSURE OF THE SOURCE OF THE INFECTION AND IS QUESTION WHETHER THE IMPLANT SHIFTED AFTER THE FALL AND CAUSED THE INFECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain; Paralysis; Sepsis

  MAUDE report 23477337 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT VIA THE ZIMMER BIOMET COMPLAINTS MAILBOX THAT THE SPF MALFUNCTIONED. THE PATIENT STATED THAT THE FUSION NEVER TOOK AND SCREWS WERE LOOSE SUGGESTING MALFUNCTION OF THE BONE GROWTH STIMULATOR RESULTING IN CONTINUED, SOMETIMES SEVERE, PAIN. THE PATIENT ALSO STATED THAT IT RESULTED IN SPINE AND POSTURE BECOMING BENT OVER, BOTH TITLED TO THE LEFT AND FORWARD. THE PATIENT HAD TO USE A WALKER AND UNDERWENT A MAJOR REVISION SURGERY (B)(6) 2024 WITH TRIPLE FUSION WHERE IT DID NOT TAKE AT L4-L5 AS WELL AS PLACEMENT OF ILIAC BOLTS TO STRAIGHTEN THE SPINE, PLUS REMOVAL OF THE STIMULATOR. THE PATIENT STATED THAT THE PAIN AND SUFFERING FROM THIS HAS BEEN PROFOUND NO FURTHER CONSEQUENCES WERE REPORTED. THE PATIENT DECLINED TO PROVIDE ADDITIONAL INFORMATION. THERE IS NO INDICATION OF DEVICE RETURN FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 22319189 ↗
• InjuryJun 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE UNIT IMPLANTED IS LISTED ON THE 2018 RECALL. THE PATIENT STATES THAT HE EXPERIENCED HORRIFIC PAIN AFTER THE UNIT WAS IMPLANTED. THE UNIT WAS EXPLANTED ABOUT 6 MONTHS LATER AND ALLEVIATED SOME PAIN BUT NOT ALL. HE HAS EXPERIENCED PAIN, MUSCLE SPASMS, INFECTIONS, AND UTIS FOR 8 YEARS. HE HAS RECEIVED DRY NEEDLING THERAPY FOR HIS MUSCLE SPASMS. LONG NEEDLES ARE STUCK DEEP INTO THE MUSCLES THAT ARE SPASMING. THE PATIENT MENTIONED HE DOES DEVELOP INFECTIONS AND UTI AFTER THE DRY NEEDLING THERAPY. HE IS UNABLE TO HAVE AN MRI BECAUSE THERE IS A PARTIAL WIRE. THE WIRES MAY HAVE BEEN CUT VS DISCONNECTED. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. OUR RESEARCH AND DEVELOPMENT DEPARTMENT STATED THAT THE SPF SHOULDN'T CAUSE ANY UTIS.

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

  MAUDE report 19600578 ↗
• InjuryJun 30, 2020Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR AN SPF-PLUS 60/M DEVICE. THE SURGEON REPORTED THAT THE SPF UNIT APPEARED TO BE CORRODED. THE SURGEON LATER STATED THAT THE DEVICE HAD A RUSTIC DISCOLORATION AND WAS NOT CORRODED. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE SPF-PLUS 60/M UNIT WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10211521 ↗
• InjuryJun 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT APPROXIMATELY 2 WEEKS AFTER UNDERGOING SURGERY FOR CERVICAL FUSION AND HAVING AN SPF BONE STIMULATOR IMPLANTED, THE PATIENT¿S SURGEON STATED THAT SHE HAD AN INFECTION, AT HER FOLLOW UP APPOINTMENT. THE SURGEON WAS AWARE OF A PREVIOUS RECALL INVOLVING THE SPF PRODUCT AND WAS CONCERNED THAT THE DEVICE MIGHT HAVE CAUSED THE INFECTION. THE SURGEON SCHEDULED THE PATIENT FOR SURGERY A DAY LATER TO EXPLANT THE DEVICE. FOLLOWING THE SURGERY, THE SALES REP FURTHER REPORTED THAT THERE WAS NO BACTERIAL INFECTION, AND THE PHYSICIAN SEEMS TO BELIEVE THAT THE PATIENT HAD A REACTION TO THE STIMULATOR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 8705747 ↗
• InjuryMay 22, 2019Nonstandard Device; Unexpected Therapeutic Results; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD THE SPF IMPLANTED APPROXIMATELY 3 YEARS AFTER BEING IMPLANTED. THE PATIENT INDICATED THAT THE DEVICE WAS EXPLANTED BECAUSE IT WAS NOT MRI SAFE. SHE STATED THAT SPF DID NOT CAUSE HER TO FEEL WELL, AND SHE EXPERIENCED PAIN. THE PATIENT STATED THAT SHE HAS HAD NO QUALITY OF LIFE FOR THE PAST 3 YEARS, AND THAT THE SPF AFFECTED HER IMMUNE SYSTEM. THE PATIENT ALSO INDICATED THAT SHE HAD A BONE GRAFT THAT NEVER HEALED DUE TO THE SPF. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8631438 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAS ISSUES WITH THE IMPLANTED SPF UNIT. SHE STATES THAT SHE FEELS LIKE SOMETHING IS WRONG, AND THAT SHE IS EXPERIENCING PAIN IN THE AREA WHERE THE UNIT IS IMPLANTED. SHE STATES THAT HER PAIN LEVEL IS 5-7 ON A SCALE OF 1-10, WITH 10 BEING THE WORST. SHE STATES THAT NO PART OF THE UNIT HAS BEEN EXPLANTED AND SHE CAN FEEL THE UNIT. THE PATIENT SPOKE TO HER SURGEON WHO STATED THAT SHE "SHOULDN'T BE ABLE TO FEEL IT". SHE STATED THAT SHE HAS TRIED TO HAVE AN MRI SCAN, BUT HAS BEEN TURNED DOWN BY 3 FACILITIES DUE TO MRI SAFETY INFORMATION FOUND ONLINE. THE PATIENT STATED THAT SHE DID VISIT A NEW DOCTOR TO TRY TO GET IT EXPLANTED BUT DOCTORS WILL NOT DO THE PROCEDURE AS THEY DO NOT WANT TO BE HELD LIABLE. THE UNIT STILL REMAINS IMPLANTED IN THE PATIENT AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8568340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P850035. One submission often covers many models, so check the product and lot details in each record.

• Z-0287-2019 · Feb 19, 2018 · Terminated
  SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of
• Z-2118-2017 · Apr 20, 2017 · Terminated
  10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
• Z-2119-2017 · Apr 20, 2017 · Terminated
  10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.