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

Model Number	148.540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported from a uk globus medical representative, that the corridor screw backed out post-operatively.

• Brand Name: CORRIDOR
• Common Device Name: 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
• Report Number: 3004142400-2020-00072
• Device Sequence Number: 20803123
• Product Code: MRW
• UDI-Device Identifier: 00849044033731
• UDI-Public: 00849044033731
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

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