MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SILC; SILC BAND

Model Number 1116.0006S

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

The bands and clamps were returned for evaluation.Upon inspection it was noted that all bands had been separated across the width and the ends had frayed.This type of band failure can only be replicated if the band has a cut or snag, and is then placed under extreme load.Evaluation of the scans provided show the clamps still in place at t8-t9 levels.It can also be noted that the screws at t10 have become loose and pulled out of the bone.It was noted that the breakage occurred in the middle of the bands, not at the clamp interface.While it is indeterminate as to the cause of the failure, it is possible the bands were nicked during insertion, frayed against hard bone, or clamp and band interference against the rod or bone.The cause of the reported issue cannot be determined.

Event Description

The patient complained of pain at t8-t9.The surgeon removed the silc implants and found all four bands had broken at the middle of the lamina bands.The surgeon removed the hardware.

• Brand Name: SILC
• Type of Device: SILC BAND
• 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: 6558629
• MDR Text Key: 74889214
• Report Number: 3004142400-2017-00025
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1116.0006S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR