EXPEDIUM 179771035Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034077550), received between May 20, 2019 and Jan 8, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT HE FELT A POP IN HIS LOW BACK WHEN HE STEPPED AROUND AN OBJECT. AN X-RAY TAKEN AT THE (B)(6) 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED "AT THE BASE OF THE MULTIAXIAL CONNECTOR." BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS "PROCEED TO FULL CONSOLIDATION," PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED HIS ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT OF (B)(6) 2024, CONSISTENT WITH HIS OPERATIVE REPORT OF (B)(6) 2024.) AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF HIS L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS OF THE (B)(6) 2024 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE SURGEON CORRECT

  Patient problems: Pain

  MAUDE report 24011851 ↗
• InjuryJan 8, 2026Break

  ON (B)(6) 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT HE FELT A POP IN HIS LOW BACK WHEN HE STEPPED AROUND AN OBJECT. AN X-RAY TAKEN AT THE (B)(6) 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED "AT THE BASE OF THE MULTIAXIAL CONNECTOR." BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS "PROCEED TO FULL CONSOLIDATION," PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED HIS ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT OF (B)(6) 2024, CONSISTENT WITH HIS OPERATIVE REPORT OF (B)(6) 2024.) AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF HIS L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS OF THE (B)(6) 2024 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE SURGEON CORRECT

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 24011464 ↗
• InjuryMay 20, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 1ST SURGERY ON (B)(6) 2018, FUSION L5-S1 WITH EXPEDIUM AND T-PAL. ON (B)(6) 2018, REVISION SURGERY BECAUSE OF RADICULOPATHY AND SUSPICION ON INFECTION. IMPLANTS WHERE LOOSE, HAVE BEEN REMOVED AND REPLACED. POST OP PAIN FREE. TISSUE HAS BEEN EXAMINED IN BACTERIOLOGY, ONE SAMPLE WAS POSITIVE. PATIENT SHOWED UP IN (B)(6) WITH BACK PAIN, EXAMINATIONS HAVE SHOWN AGAIN PSEUDARTHROSIS AND LOOSENING OF THE IMPLANTS. ON (B)(6), AGAIN REVISION SURGERY, REMOVAL OF ALL IMPLANTS, WHICH HAVE BEEN SENT IN FOR BACTERIOLOGICAL EXAMINATION. SEVERAL TISSUE SAMPLES WILL ALSO BE EXAMINED BACTERIOLOGICALLY. T-PAL CAGE WILL BE REMOVED FROM ANTERIOR AFTER THESE RESULTS OF THE BACTERIOLOGICAL EXAMINATION ARE KNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8623634 ↗
• InjuryMay 20, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 1ST SURGERY ON (B)(6) 2018, FUSION L5-S1 WITH EXPEDIUM AND T-PAL. ON (B)(6) 2018, REVISION SURGERY BECAUSE OF RADICULOPATHY AND SUSPICION ON INFECTION. IMPLANTS WHERE LOOSE, HAVE BEEN REMOVED AND REPLACED. POST OP PAIN FREE. TISSUE HAS BEEN EXAMINED IN BACTERIOLOGY, ONE SAMPLE WAS POSITIVE. PATIENT SHOWED UP IN (B)(6) WITH BACK PAIN, EXAMINATIONS HAVE SHOWN AGAIN PSEUDARTHROSIS AND LOOSENING OF THE IMPLANTS. ON (B)(6), AGAIN REVISION SURGERY, REMOVAL OF ALL IMPLANTS, WHICH HAVE BEEN SENT IN FOR BACTERIOLOGICAL EXAMINATION. SEVERAL TISSUE SAMPLES WILL ALSO BE EXAMINED BACTERIOLOGICALLY. T-PAL CAGE WILL BE REMOVED FROM ANTERIOR AFTER THESE RESULTS OF THE BACTERIOLOGICAL EXAMINATION ARE KNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8623427 ↗