SpF XL IIb Implantable Spinal Fusion Stimulator 10-1335MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00812301020089), received between May 21, 2019 and May 24, 2023 — classified as 7 injuries.

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

• InjuryMay 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT'S SPF WAS EXPLANTED DUE TO PAIN. THE PATIENT'S IMPLANT DATE WAS (B)(6) 2022 AT HMH BAYSHORE MEDICAL CENTER. THE IMPLANTED SPF WAS SPF XL IIB, 2/DM - 10-1335M, SERIAL NUMBER (B)(6). ADDITIONAL CONTACT AND DEMOGRAPHIC DETAILS ON THE PATIENT ARE NOT AVAILABLE. ADDITIONAL DETAILS ON THE PATIENT'S EXPERIENCE ARE NOT AVAILABLE. NO REPLACEMENTS TO OUR KNOWLEDGE. THE PATIENT STATED, "WE BELIEVE THE WIRE BROKE AFTER A REAR END MVA ABOUT A YEAR AFTER IMPLANTATION. MY SURGEON DID TAKE OUT THE BATTERY PART OF THE TIME. BUT THE CATHODES ARE STILL IN MY CERVICAL AREA. THE PATIENT STATED THAT THE ISSUE IS GETTING A FACILITY TO TAKE AN MRI NEEDED OF MY HIP AND ELBOW AREA. THE PATIENT WAS TOLD TO CONTACT ZIMVIE. THE PATIENT WAS NOT SENT A REPLACEMENT PRODUCT. THE PRODUCT IS NOT EXPECTED TO BE RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 16991739 ↗
• InjuryJun 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THE STIMULATOR SPINAL FUSION REMOVED DUE TO PAIN. THE PATIENT IS A 66-YEAR-OLD MALE WITH HISTORY OF PRIOR POSTERIOR CERVICAL THORACIC FUSION WITH AN IMPLANTED BONE GROWTH STIMULATOR WHO NOW PRESENTS FOR ELECTIVE EXPLANATION OF THE BONE STIMULATOR GENERATOR AS PER MANUFACTURER RECOMMENDATION. THE REASON FOR THE REMOVAL WAS DUE TO INTERMITTENT PAIN THE PATIENT HAS BEEN EXPERIENCING IN THE AREA OF THE BONE STIMULATOR AND REQUESTED AN ELECTIVE EXPLANATION OF THE BONE STIMULATOR GENERATOR AS PER MANUFACTURER RECOMMENDATION. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE SPF XL WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 11967570 ↗
• InjuryAug 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN INTERACTION BETWEEN THE SPF XL IIB 2/DM AND THE COBALT CHROME OF THE POLARIS TRANSLATION SCREWS. AS A RESULT, MULTIPLE SCREWS DISASSEMBLED. A REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREWS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10367782 ↗
• InjuryMay 8, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE SPF-XL IIB 2/DM WHICH RESULTED IN AN EXPLANT OF THE DEVICE. IT WAS REPORTED THAT THE LEAD OF THE SPF DEVICE WAS UNPLUGGED. THE DEVICE WAS EXPLANTED AND A REPLACEMENT SPF WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10038520 ↗
• InjuryNov 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHARP PAIN IN HIS LOWER BACK. THE PAIN INTENSIFIED AND THE PATIENT WAS UNABLE TO MOVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THREE DAYS. THE DOCTORS AT THE HOSPITAL TOLD THE PATIENT THAT IT WAS A SEVERE MUSCLE SPASM. THE PATIENT WAS GIVEN PAIN MEDICATION. THE PATIENT WAS PRESCRIBED MEDICATIONS UPON RELEASE. THE PATIENT HAS FOLLOWED UP WITH HIS GENERAL PRACTITIONER AND STATES THAT HE IS IN GOOD HEALTH AND HAS NOT HAD ANY PROBLEMS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle Spasm(s); Pain

  MAUDE report 9289682 ↗
• InjurySep 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TWO MONTHS POST IMPLANTATION OF THE SPF-XL IIB 2/DM. THE PATIENT UNDERWENT A REVISION OF HIS LUMBAR FUSION DUE TO LOOSENING OF THE PEDICLE SCREW WITH SIMULTANEOUS IMPLANTATION OF THE SUBCUTANEOUS SPINAL STIMULATOR. AFTER SURGERY, THE PATIENT DEMONSTRATED IMPROVEMENT WITH PAIN AND MOTION. AT SIX WEEKS POSTOP, A SUTURE ABSCESS WAS NOTED AND TREATED WITH ANTIBIOTICS. DUE TO THE DEVICE RECALL AND ABSCESS, THE PATIENT UNDERWENT ELECTIVE REMOVAL OF THE SPINAL STIMULATOR. DURING THE REMOVAL, NO SIGN OF INFECTION WAS NOTED WITH DEEP EXPLORATION. THE WOUND WAS IRRIGATED AND CLOSED. (WOUND AND DEVICE CULTURE REPORTS ARE INCLUDED IN SECTION B7) THE PATIENT WAS SUBSEQUENTLY READMITTED FOR SEPSIS ATTRIBUTED TO THE LUMBAR WOUND. A SECOND INCISION AND DRAINAGE WAS PERFORMED, AND THE PATIENT WAS TREATED BY AN INFECTIOUS DISEASE SPECIALIST. THE PATIENT WAS DISCHARGED HOME FROM LONG TERM CARE WITHOUT FURTHER COMPLICATION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Abscess; Necrosis; Pain; Sepsis; Swelling; Unspecified Infection

  MAUDE report 9115177 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF NERVE PAIN, CHRONIC PAIN, SWELLING, INFLAMMATION AND ALSO INFECTION. THE PATIENT HAD THE SPF DEVICE IMPLANTED FOR 12 YEARS. THE PATIENT ALSO STATED THAT SHE HAD URINE PROBLEMS, COULD NOT EMPTY HER BLADDER, AND HAD TO USE ANTIBIOTIC FOR PAIN. THE PATIENT STATED THAT NO PHYSICIAN WOULD REMOVE THE DEVICE. THE PATIENT STATED THAT SHE HAD THE DEVICE REMOVED EARLIER THIS YEAR BY A PAIN MANAGEMENT DOCTOR. THE PATIENT STATED THAT AFTER EXPLANATION OF THE DEVICE, THE INFECTIONS AND HORRIBLE PAIN CLEARED, AND THE ABILITY TO LIVE IS COMING BACK. THE PATIENT INDICATED THAT SHE CONTINUES TO USE ANTIBIOTICS AND THAT SHE IS GOING TO PAIN MANAGEMENT. THE PATIENT WANTED TO KNOW WHETHER THERE WAS A RECALL ON THE SPF MODEL THAT SHE WAS TREATED WITH. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8627837 ↗

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-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.
• 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.