X-PAC EI2511LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850001720298), received between Dec 22, 2021 and Dec 10, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Migration; Migration

  AN X-PAC 10MM X 25MM LORDOTIC CAGE THAT WAS IMPLANTED ON (B)(6) 2025 ON A FEMALE PATIENT WAS REPORTED PER (B)(4) TO HAVE SLIPPED ANTERIORLY, NECESSITATING A REVISION SURGERY ON (B)(6) 2025. THIS IS THE ONLY PATIENT CONSEQUENCE KNOWN TO DATE.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 23773940 ↗
• InjuryMar 24, 2022Migration

  IT WAS REPORTED BY THE DISTRIBUTOR REPRESENTATIVE THAT POSTERIOR SPINAL FUSION SURGERY HAD BEEN PERFORMED ON A FEMALE PATIENT AT L5/S1 ON (B)(6) 2021. DURING PATIENT FOLLOW UP VISIT TO DOCTOR ON (B)(6) 2022, IT WAS OBSERVED THAT MIGRATION OF THE IMPLANTED CAGE HAD OCCURRED POSTERIORLY AND THAT THE CAGE WAS IMPINGING ON THE NERVE. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2022. ON (B)(6) 2022, IT WAS REPORTED THAT THE REVISION SURGERY HAD TAKEN PLACE ON THE SCHEDULED DATE.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 13892291 ↗
• InjuryDec 22, 2021Migration or Expulsion of Device

  IT WAS REPORTED BY A SALES CONSULTANT ON 11/3/2021 THAT ON AN UNKNOWN DATE, THE SURGEON REPORTED THAT THE PATIENT HAD RETRO PULSING OF AN EXPANDABLE TLIF CAGE. THE SURGEON ALLUDED TO LOWERING THE CAGE AND IMPACTING IT FURTHER INTO THE DISC SPACE WHICH INITIATED THIS COMPLAINT. IT WAS UNKNOWN AT THAT TIME IF THE SURGERY WOULD BE RESCHEDULED. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVED ONE (1) DEVICE. THIS HAPPENED DURING A PLIF PROCEDURE IN WHICH TWO (2) CAGES ARE IMPLANTED INTO A DISC SPACE. ON A FOLLOW UP CALL TO THE SALES CONSULTANT ON 11/23/2021 HE REPORTED THAT · ON (B)(6) THE SURGEON COMPLETED A REVISION. HE REMOVED THE "LOOSE" X-PAC CAGE AND SUCCESSFULLY REPLACED IT WITH ANOTHER X-PAC CAGE. · THE SURGEON STATED THAT HE THOUGHT HE INITIALLY LEFT THE FIRST CAGE TOO LOOSE AFTER HE PUT IN THE 2ND CAGE CAUSING IT TO MIGRATE POSTERIORLY. · THE SALES REPRESENTATIVE RETAINED THE CAGE AND DID HIS OWN REVIEW AND THOUGHT THE EXPLANTED CAGE WORKED NORMALLY.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 13060588 ↗