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EXPEDIUM 179715650Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 x 6.5 x 50mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034068596), received between Aug 21, 2025 and Aug 22, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2

Patient problems

  • Bone Fracture(s)1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2025Break; Break

    IT WAS REPORTED THAT 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. (TH

    Patient problems: Bone Fracture(s)

    MAUDE report 22873380 ↗
  • InjuryAug 21, 2025Break; Break

    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) 24, 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 CORRECTED

    Patient problems: Pain

    MAUDE report 22866046 ↗

Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices

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Sources and updates

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