MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SILC; SILC 5.5MM INLINE CLAMP

Model Number 1116.0155

Device Problems Positioning Failure (1158); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Three of the four clamps were returned for evaluation.Additional information provided that these clamps were not used in a manner consistent with the surgical technique guide.One clamp was placed on each side of the spine and one band was fed across the spine in an attempt to compress a pars fracture.The clamps are intended to receive one band per clamp.It is possible that the cause is user technique, excessive force, improper engagement with the rod and interface with anatomy; however, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done due to clamps that pulled off the rod post-operatively.During the revision the replacement clamps would not stay on the rod.

• Brand Name: SILC
• Type of Device: SILC 5.5MM INLINE CLAMP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11340490
• MDR Text Key: 233747518
• Report Number: 3004142400-2021-00027
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00889095029208
• UDI-Public: 00889095029208
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1116.0155
• Device Lot Number: FCW259AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• 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