MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CORRIDOR; 4.5MM CANNULATED BONE SCREW, 40MM

Model Number 148.540

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Investigation found that during the initial surgery, the screw drive feature stripped during insertion into the l5-s1 level for a pars fracture repair.The surgeon was unable to remove the screw and it was advanced fully into the bone using grips/tools along the outside of the screw head.Imaging taken approximately three months post-operative, showed the screw had backed out about 13mm of its length.Evaluation of the returned screw found no apparent damage on the threaded or smooth portions of the screw shank.The hex drive feature has been stripped and there are scratches and marks along the head of the screw.The drive feature stripping is indicalfve of excessive insertion forces.It's possible that advancing the screw using vice grips affected the efficacy of the bone screw threads at full depth as non-axial rotation may h,we expanded the hole the screw created and allowed the screw to back out.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported from a uk globus medical representative, that the corridor screw backed out post-operatively.

• Brand Name: CORRIDOR
• Type of Device: 4.5MM CANNULATED BONE SCREW, 40MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18827595
• MDR Text Key: 336873769
• Report Number: 3004142400-2020-00072
• Device Sequence Number: 1
• Product Code: MRW
• UDI-Device Identifier: 00849044033731
• UDI-Public: 00849044033731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 148.540
• Device Lot Number: BGJ143AB
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Race: White