EXPEDIUM 179963450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034091679), received between Dec 12, 2018 and May 14, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD T9-PELVIS POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2016. DURING A ROUTINE CLINIC FOLLOW UP VISIT ON (B)(6) 2019, IT WAS FOUND THAT PATIENT HAD BROKEN RODS (PART 1799-63-450) AT L3 AND A FRACTURED SCREW (PART 1799-12-899) AT THE RIGHT ILIUM. LIKELY CAUSE WAS NON-UNION AT L2-3. X-RAY AND CT SCANS WERE DONE TO CONFIRM. REVISION SURGERY OCCURRED ON (B)(6) 2019. BROKEN HARDWARE WAS REMOVED AND REVISED TO CORRECT THE NON-UNION. THE IMPLANTS WERE DISCARDED BY THE HOSPITAL AND ARE NOT AVAILABLE TO SHIP TO DEPUY FOR EVALUATION. THE LOT NUMBER OF THESE ITEMS IS NOT KNOWN. BOTH SURGERIES OCCURRED AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: No Code Available

  MAUDE report 8609484 ↗
• InjuryMay 14, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD T9-PELVIS POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2016. DURING A ROUTINE CLINIC FOLLOW UP VISIT ON (B)(6) 2019, IT WAS FOUND THAT PATIENT HAD BROKEN RODS (PART 1799-63-450) AT L3 AND A FRACTURED SCREW (PART 1799-12-899) AT THE RIGHT ILIUM. LIKELY CAUSE WAS NON-UNION AT L2-3. X-RAY AND CT SCANS WERE DONE TO CONFIRM. REVISION SURGERY OCCURRED ON (B)(6) 2019. BROKEN HARDWARE WAS REMOVED AND REVISED TO CORRECT THE NON-UNION. THE IMPLANTS WERE DISCARDED BY THE HOSPITAL AND ARE NOT AVAILABLE TO SHIP TO DEPUY FOR EVALUATION. THE LOT NUMBER OF THESE ITEMS IS NOT KNOWN. BOTH SURGERIES OCCURRED AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: No Code Available

  MAUDE report 8609362 ↗
• InjuryDec 12, 2018Break; Break

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED ON UNKNOWN DATE TO FIX THORACIC SPINE (POSITION WAS UNKNOWN) TO S2 WITH EXPEDIUM 6.35 SYSTEM VIA POSTERIOR SPINE FUSION, HOWEVER, BOTH ROD ENDS WERE NOT CONNECTED. ON (B)(6) 2018, THE REINFORCEMENT SURGERY WAS PLANNED TO REVISE THE ROD WHERE IMPLANTED TO SUPERIOR HEAD SIDE, AND THE CONNECT WITH NEW ROD TO REINFORCE THE CONNECTION. AT THAT TIME, THE SALES REP HEARD THE SYSTEM NAME WHICH HAD BEEN IMPLANTED WAS JUST ¿EXPEDIUM¿ FROM THE DOCTOR, SO HE THUS, THE SALES FORCE PREPARED ALL KINDS IMPLANTS OF CONNECTOR I.E. SIDE-SIDE, END-END, UNIVERSAL, LATERAL, TRANSVERSE (P/N AND LOT NUMBER WERE UNKNOWN), NEW RODS (P/N AND LOT NUMBER WERE UNKNOWN), AND DI SCREW (9MM AND 10MM, P/N AND LOT NUMBER WERE UNKNOWN) OF EXPEDIUM 5.5 SYSTEM. THEN, ON (B)(6) 2018, THE REINFORCEMENT SURGERY WAS PERFORMED. DURING THE SURGERY, THE SURGEON RECOGNIZED THAT THE INFERIOR TAIL SIDE SCREW WAS LOOSENED WHEN REMOVED THE SET SCREW AND ROD, SO THAT THE SURGEON TRIED TO REMOVE THE SCREW UNDERNEATH BY USING INSITU ROD BENDER. HOWEVER, THE ROD BENDER WAS NOT FIT THE ROD, AND THEN, IT WAS JUST NOTICED THE SURGEON RECOGNIZED THE ALL IMPLANTS WERE EXPEDIUM 6.35 SYS

  Patient problems: No Code Available

  MAUDE report 8156490 ↗