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EXPEDIUM 179712399Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 x 12 x 100mm · Class 2 · Implant

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034067339), received between Jul 24, 2019 and Jul 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K101993); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Loose or Intermittent Connection1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryJul 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE ROD THAT WAS BROKEN BILATERALLY AND THE DISTAL SCREWS WERE LOOSENED. BROKEN ENDS OF ROD CATALOG # 1797-62-480, VERSE SCREW, 1997-21-750 X QTY 1, VERSE SCREW 1997-21-745 X QTY 1 AND 9.0X90MM SAI SCREWS 1797-04-990 X QTY 2 WERE ALL REMOVED TO REVISE. A 12.0X100MM SCREW, 1797-12-399 WAS REMOVED WITH PLIERS DUE TO THE FIRST OF TWO SCREWDRIVER TIPS BREAKING. THIS SCREW WAS NOT RECOVERED TO RETURN. THERE WERE NO FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

    Patient problems: No Code Available

    MAUDE report 8821903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101993. One submission often covers many models, so check the product and lot details in each record.

  • Z-0713-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
  • Z-0707-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.
  • Z-0710-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
  • Z-0712-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
  • Z-0705-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
  • Z-0708-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
  • Z-0709-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
  • Z-0706-2013 · Nov 7, 2012 · Terminated
    DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.

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Sources and updates

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