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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812301020096), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN WITH THE ZIMMER BIOMET SPF XL IIB 2/DW IMPLANT, AND THE MRI PERFORMED BY GROSSMAN IMAGING CENTER. THE SPF XL IIB 2/DW WAS IMPLANTED IN A LUMBAR SURGERY IN 2017 BY (B)(6). THE SUMMER OF 2021 THE PATIENT VISITED (B)(6) FOR AN MRI PRIOR TO IMPLANT REMOVAL SURGERY. IT WAS STATED THAT "ZIMMER BIOMET NEGLIGENTLY EVALUATED THE SAFETY OF THE BONE STIMULATOR AND HAD INSUFFICIENT DATA TO JUSTIFY THE SPF XL IIB 2/DW BONE STIMULATOR BEING LABELS AS CONDITIONALLY SAFE, ESPECIALLY ONCE MORE POWERFUL MRIS BEGAN TO BE COMMONLY USED. FURTHER, DEFENDANT ZIMMER BIOMET NEGLIGENTLY DESIGNED THE BONE STIMULATOR SUCH THAT ITS ELECTRICAL CONDUCTIVITY WAS GREATER THAN REPRESENTED IN ITS WARNINGS AND MARKETING MATERIALS." LIMAS, A PATIENT WITH A BACK CONDITION, WAS SCANNED BY A TECHNICIAN ABOUT THE PRESENCE OF A BONE STIMULATOR. THE IMAGING CENTER WAS INFORMED ABOUT THIS AND A C-T STUDY HAD BEEN DONE AT (B)(6) TWO WEEKS EARLIER. LIMAS WAS PREPARED FOR THE MRI, BUT AFTER THE EXAM, HE BEGAN SCREAMING IN PAIN AND WAS ASKED TO SIT QUIETLY. THE TECHNICIAN INSTRUCTED HIM TO TAKE PAIN MEDICATION FROM DEFENDANT ARCHE THE FOLLOWING DAY AND TO RETRY THE MRI TWO

  Patient problems: Pain

  MAUDE report 18938236 ↗

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.