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

Model Number	1116.0155
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SILC 5.5MM INLINE CLAMP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11340490
• Report Number: 3004142400-2021-00027
• Device Sequence Number: 11784291
• Product Code: OWI
• UDI-Device Identifier: 00889095029208
• UDI-Public: 00889095029208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 02/12/2021

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: 1116.0155
• Device Lot Number: FCW259AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other