MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. GLOBUS THREADED ROD; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 6135.0010

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2020

Event Type  malfunction  

Event Description

Globus threaded rod tip sheared off during procedure (anterior lumbar interbody fusion with pedicle screw fixation).The tip was embedded in the cage and the surgeon was unable to remove.Intentionally retained.Fda safety report id# (b)(4).

• Brand Name: GLOBUS THREADED ROD
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; audubon PA 19403
• MDR Report Key: 10534922
• MDR Text Key: 207161172
• Report Number: MW5096607
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095311297
• UDI-Public: (01)00889095311297(10)JNW308CD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6135.0010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 84