EXPEDIUM 179732740Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034074030), received between Jan 14, 2022 and Aug 10, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018 THE PATIENT UNDERWENT A PRIMARY PROCEDURE (L3-S) AND 7.0MM (DIAMETER) SCREWS WERE APPLIED. ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SCREW AT L3 HAD BEEN LOOSE. THE 2ND PROCEDURE (1ST REMOVAL) WAS DONE ON (B)(6) 2018 TO REMOVE THE LOOSE SCREW AND DEPLOY A REPLACING SCREW (10MM IN DIAMETER). ALSO, THE FUSION WAS EXTENDED UP TO L1. SCREWS (7 X 40MM) WERE APPLIED TO L1 AND L2. NEXT, IT WAS CONFIRMED ON AN UNKNOWN DATE THAT THE SCREWS AT L1 AND L2 HAD GRADUALLY BACKED OUT, APPROXIMATELY A HALF THE LENGTH OF THE SCREW AT L1 HAD COME OFF THE LESION. THE PATIENT SUFFERED FROM PRESSURE ULCER DUE TO THIS L1 BACKED-OUT SCREW. FURTHERMORE, A TEST ON THE PATIENT¿S INFECTION MEASURED CRP15 AND WBC24000. THEY HAD THE PATIENT TAKE ANTIBIOTICS AND VANCOMYCIN FOR AN UPCOMING REMOVAL PROCEDURE. THE PATIENT UNDERWENT ANOTHER REMOVAL PROCEDURE ON (B)(6) 2022. ALL THE FORMERLY IMPLANTED DEVICES (12 SCREWS, 2 RODS, 12 SETSCREWS AND 2 CROSS-LINKS) WERE REMOVED. THE L1 SCREW WAS SENT FOR CULTIVATION TEST ON THE PATIENT¿S INFECTION. THE SURGEON CONFIRMED THAT THE EVENT HAD NOT BEEN TRIGGERED BY THE IMPLANT

  Patient problems: Pocket Erosion

  MAUDE report 15204363 ↗
• InjuryAug 10, 2022Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018 THE PATIENT UNDERWENT A PRIMARY PROCEDURE (L3-S) AND 7.0MM (DIAMETER) SCREWS WERE APPLIED. ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SCREW AT L3 HAD BEEN LOOSE. THE 2ND PROCEDURE (1ST REMOVAL) WAS DONE ON (B)(6) 2018 TO REMOVE THE LOOSE SCREW AND DEPLOY A REPLACING SCREW (10MM IN DIAMETER). ALSO, THE FUSION WAS EXTENDED UP TO L1. SCREWS (7 X 40MM) WERE APPLIED TO L1 AND L2. NEXT, IT WAS CONFIRMED ON AN UNKNOWN DATE THAT THE SCREWS AT L1 AND L2 HAD GRADUALLY BACKED OUT, APPROXIMATELY A HALF THE LENGTH OF THE SCREW AT L1 HAD COME OFF THE LESION. THE PATIENT SUFFERED FROM PRESSURE ULCER DUE TO THIS L1 BACKED-OUT SCREW. FURTHERMORE, A TEST ON THE PATIENT¿S INFECTION MEASURED CRP15 AND WBC24000. THEY HAD THE PATIENT TAKE ANTIBIOTICS AND VANCOMYCIN FOR AN UPCOMING REMOVAL PROCEDURE. THE PATIENT UNDERWENT ANOTHER REMOVAL PROCEDURE ON (B)(6) 2022. ALL THE FORMERLY IMPLANTED DEVICES (12 SCREWS, 2 RODS, 12 SETSCREWS AND 2 CROSS-LINKS) WERE REMOVED. THE L1 SCREW WAS SENT FOR CULTIVATION TEST ON THE PATIENT¿S INFECTION. THE SURGEON CONFIRMED THAT THE EVENT HAD NOT BEEN TRIGGERED BY THE IMPLANT

  Patient problems: Pocket Erosion

  MAUDE report 15204316 ↗
• InjuryAug 10, 2022Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018 THE PATIENT UNDERWENT A PRIMARY PROCEDURE (L3-S) AND 7.0MM (DIAMETER) SCREWS WERE APPLIED. ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SCREW AT L3 HAD BEEN LOOSE. THE 2ND PROCEDURE (1ST REMOVAL) WAS DONE ON (B)(6) 2018 TO REMOVE THE LOOSE SCREW AND DEPLOY A REPLACING SCREW (10MM IN DIAMETER). ALSO, THE FUSION WAS EXTENDED UP TO L1. SCREWS (7 X 40MM) WERE APPLIED TO L1 AND L2. NEXT, IT WAS CONFIRMED ON AN UNKNOWN DATE THAT THE SCREWS AT L1 AND L2 HAD GRADUALLY BACKED OUT, APPROXIMATELY A HALF THE LENGTH OF THE SCREW AT L1 HAD COME OFF THE LESION. THE PATIENT SUFFERED FROM PRESSURE ULCER DUE TO THIS L1 BACKED-OUT SCREW. FURTHERMORE, A TEST ON THE PATIENT¿S INFECTION MEASURED CRP15 AND WBC24000. THEY HAD THE PATIENT TAKE ANTIBIOTICS AND VANCOMYCIN FOR AN UPCOMING REMOVAL PROCEDURE. THE PATIENT UNDERWENT ANOTHER REMOVAL PROCEDURE ON (B)(6) 2022. ALL THE FORMERLY IMPLANTED DEVICES (12 SCREWS, 2 RODS, 12 SETSCREWS AND 2 CROSS-LINKS) WERE REMOVED. THE L1 SCREW WAS SENT FOR CULTIVATION TEST ON THE PATIENT¿S INFECTION. THE SURGEON CONFIRMED THAT THE EVENT HAD NOT BEEN TRIGGERED BY THE IMPLAN

  Patient problems: Pocket Erosion

  MAUDE report 15204246 ↗
• InjuryAug 10, 2022Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018 THE PATIENT UNDERWENT A PRIMARY PROCEDURE (L3-S) AND 7.0MM (DIAMETER) SCREWS WERE APPLIED. ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SCREW AT L3 HAD BEEN LOOSE. THE 2ND PROCEDURE (1ST REMOVAL) WAS DONE ON (B)(6) 2018 TO REMOVE THE LOOSE SCREW AND DEPLOY A REPLACING SCREW (10MM IN DIAMETER). ALSO, THE FUSION WAS EXTENDED UP TO L1. SCREWS (7 X 40MM) WERE APPLIED TO L1 AND L2. NEXT, IT WAS CONFIRMED ON AN UNKNOWN DATE THAT THE SCREWS AT L1 AND L2 HAD GRADUALLY BACKED OUT, APPROXIMATELY A HALF THE LENGTH OF THE SCREW AT L1 HAD COME OFF THE LESION. THE PATIENT SUFFERED FROM PRESSURE ULCER DUE TO THIS L1 BACKED-OUT SCREW. FURTHERMORE, A TEST ON THE PATIENT¿S INFECTION MEASURED CRP15 AND WBC24000. THEY HAD THE PATIENT TAKE ANTIBIOTICS AND VANCOMYCIN FOR AN UPCOMING REMOVAL PROCEDURE. THE PATIENT UNDERWENT ANOTHER REMOVAL PROCEDURE ON (B)(6) 2022. ALL THE FORMERLY IMPLANTED DEVICES (12 SCREWS, 2 RODS, 12 SETSCREWS AND 2 CROSS-LINKS) WERE REMOVED. THE L1 SCREW WAS SENT FOR CULTIVATION TEST ON THE PATIENT¿S INFECTION. THE SURGEON CONFIRMED THAT THE EVENT HAD NOT BEEN TRIGGERED BY THE IMPLANT

  Patient problems: Pocket Erosion

  MAUDE report 15204186 ↗
• MalfunctionJan 14, 2022Detachment 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 THAT DURING INCOMING INSPECTION OF THE DEVICES IT WAS NOTED THAT THE TWO (2) ROD SLOTS WERE FELL APART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SI POLYAXL EXT TAB 7 X 40MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261222 ↗
• MalfunctionJan 14, 2022Detachment 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 THAT DURING INCOMING INSPECTION OF THE DEVICES IT WAS NOTED THAT THE TWO (2) ROD SLOTS WERE FELL APART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SI POLYAXL EXT TAB 7 X 40MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261149 ↗