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
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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