MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSITION; TRANSITION 2-LEVEL IMPLANT, 60MM ROD, X-LORDOTIC, 22MM

Model Number 152.612

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

An image was provided showing the broken transition 2-level implant, 60mm rod, x-lordotic, 22m, which was removed during surgery.The spool portion of the rod subcomponent appears to have broken adjacent to the cord grip.The cord shows to have remained intact between the cord grip and the crimp housing/pin.The implant was not returned for evaluation and the exact cause of the implant breakage cannot be determined.

Event Description

It was reported on (b)(6) 2018 that a transition implant broke and needed to be removed.

Manufacturer Narrative

Initial visual inspection revealed the end spool portion of the implant had fractured between the cord grip and the rod.The fracture line was clean and ran around the diameter of the end spool.The semi-rigid portion of the implant appeared in good condition.There were scratches on the rod and spool portions of the implant, which are consistent with the use of surgical instruments.The spacer and bumper were intact with minimal deformation.The results of the dimensional inspection found all dimensions to be within tolerance.Information provided by the patient did not include incidence of a traumatic event or abnormal activity level that would cause this failure.The exact cause of the fracture could not be determined with the available information.

Event Description

It was reported on (b)(6) 2018 that a transition implant broke and needed to be removed.

• Brand Name: TRANSITION
• Type of Device: TRANSITION 2-LEVEL IMPLANT, 60MM ROD, X-LORDOTIC, 22MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• MDR Report Key: 7297610
• MDR Text Key: 101161088
• Report Number: 3004142400-2018-00007
• Device Sequence Number: 1
• Product Code: NQP
• UDI-Device Identifier: 00849044023992
• UDI-Public: 00849044023992
• Combination Product (y/n): N
• PMA/PMN Number: K073439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 152.612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other