EXPEDIUM 179712990Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034068336), received between Aug 4, 2017 and Feb 18, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PELVIC SURGERY ON THE RIGHT SIDE, THE SURGEON PREPPED THE PELVIS FOR SCREW INSERTION. THE SURGEON USED A PEDICLE FINDER TO CREATE A TRACK AND THEN TAPPED THE INTENDED SCREW HOLE. A SCREW WAS SELECTED AND LOADED ONTO THE SCREWDRIVER. THE SCREW WAS INSERTED UNDER NORMAL FORCE. AN X-RAY WAS TAKEN AND AT THIS POINT THE SEMI INSERTED SCREW WAS DISENGAGED FROM THE SCREWDRIVER. X-RAY WAS TAKEN AND THEN THE SCREWDRIVER WAS REATTACHED. THE SURGEON THEN BEGAN TO STRUGGLE TO ADVANCE THE SCREW AND SIGNIFICANTLY MORE FORCE WAS REQUIRED. THE SCREW STOPPED ADVANCING, THE DRIVER WAS DISENGAGED, IT WAS NOTED THAT THE DISTAL END OF THE SCREWDRIVER HAD BROKEN OFF INSIDE THE SCREW SHAFT THUS PREVENTING ADVANCEMENT. IT WAS DECIDED TO PLACE A ROD IN THE SCREWHEAD, LOCK THE ROD DOWN WITH A SET SCREW AND ¿HELICOPTER¿ THE SCREW OUT. THIS UNFORTUNATELY LED TO THE TULIP SHEARING OFF THE SCREW SHAFT. THE BROKEN SCREW SHAFT WAS NOW STUCK IN THE PELVIS AND HAD TO BE BURRED OUT. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE SCREW WITH A SCREW REMOVAL KIT AND OTHER INSTRUMENTATION. ON LEFT SIDE OF THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559414 ↗
• MalfunctionNov 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, DURING A SPONDYLODESIS SURGERY TO EXTENT L5 TO ILEUM THE SCREW HEAD GOT DISCONNECTED FROM THE SCREW DURING ALIGNMENT OF THE POLYAXIAL HEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY (30) MINUTES SURGICAL DELAY. THIS REPORT IS FOR ONE (1) EXP TI POLY SCREW 9MMX90MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868906 ↗
• InjuryMar 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT HAD A T10-S1 POSTERIOR SPINAL FUSION WITH DEPUY EXPEDIUM 5.5 MM TI ROD SYSTEM ON (B)(6) 2018. THE LEFT ROD RAN FROM T10-L5 AND THE RIGHT SIDE RAN FROM T10-S1 - ON BOTH SIDES THERE WERE A NUMBER OF LEVELS THAT NO SCREWS WERE PLACED. ACCORDING TO DR. (B)(6) THE PATIENT HAD A SOLID FUSION IN THE LUMBAR SPINE. AT AN UNKNOWN TIME, THE RIGHT S1 SCREW CAME LOOSE FROM THE ROD. IT IS UNKNOWN HOW THIS WAS DETERMINED. THERE WERE NO ISSUE WITH THE LEFT SIDE HARDWARE. DR. (B)(6) COMMENTED THAT HE PROBABLY SHOULD HAVE INITIALLY TAKEN THE CONSTRUCT TO THE ILIUM. HE SAID THAT THE PATIENT WAS LARGE AND THAT THERE WAS TOO MUCH STRESS ON THE HARDWARE. ON (B)(6) 2018 DR. (B)(6) PERFORMED THE REVISION. DR. (B)(6) CUT THE EXISTING RODS AROUND THE L4 LEVEL. HE REMOVED THE DISTAL PARTS OF THESE RODS. HE THEN PLACED NEW SCREWS IN THE LEFT S1 PEDICLE AND THE RIGHT L5 PEDICLE (THERE WERE NO SCREWS HERE FROM THE PREVIOUS CASE. HE THEN PLACED ILIAC SCREWS IN THE PATIENT. WHILE PUTTING IN THE RIGHT ILIAC SCREW (9.0 X 90 MM) THE TIP OF THE EXPEDIUM NAV DRIVER (279734000N) BROKE OFF IN THE HEAD OF THE SCREW. I NEED A REPLACEMENT FOR THIS DRIVER. I WILL SEND IN THE BROKEN ONE. DR. (B)(6) USED A METAL C

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7352505 ↗
• MalfunctionAug 4, 2017Break; Break

  ON THE NIGHT OF FRIDAY, (B)(6) 2017, DOCTOR WAS PERFORMING AN L4-ILIUM POSTERIOR SPINAL FUSION WITH BILATERAL SCREW FIXATION AT L4, L5, S1 AND ILIUM. THE SURGEON WAS IMPLANTING A 9.0 X 90 MM SCREW AFTER TAPPING WITH A 7.0 MM TAP. AS THE SCREW WAS BEING IMPLANTED, THE TIP OF THE DRIVER (ITEM #: 2797-34-000N) BROKE OFF INSIDE OF THE SCREW. THE SURGEON WAS UNABLE TO REMOVE OR ADVANCE THE SCREW BECAUSE HE COULD NOT ENGAGE IT DUE TO THE DRIVER TIP BEING SHEERED OFF INSIDE. AT THAT POINT, THE SURGEON DECIDED TO PLACE A SHORT ROD IN THE SCREW AND LOCK IT USING A SET SCREW. ONCE THE ROD WAS SECURELY LOCKED, WHILE SPINNING THE SCREW/ROD IN A COUNTERCLOCKWISE DIRECTION, THE TULIP HEAD OF THE SCREW BROKE OFF. USING THE SPINAL REMOVAL KIT, THE SURGEON WAS ABLE TO USE A TREPHINE TO CREATE ROOM AROUND THE SCREW AND THEN ENGAGE A BROKEN SCREW REMOVAL TOOL TO SUCCESSFULLY REMOVE IT. ONCE THE SCREW WAS OUT, THE SURGEON PLACED A 10 X 80 MM SCREW IN ITS PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769102 ↗

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-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-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-0706-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 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-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-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-0713-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 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.