MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS LOCKING CAP

Model Number 1134.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided shows that a single locking cap appears to no longer be retained in the screw head.It is unclear if an s1 screw has loosened based on the images provided.The exact cause of the reported issue could not be determined.

Event Description

It was reported that the l5 locking cap and s1 screw have loosened post-operatively.A revision surgery is scheduled.

Manufacturer Narrative

The device was returned for evaluation and visual observation shows markings consistent with normal use.The imaging provided shows that a single locking cap appears to no longer be retained in the screw head.Functional testing showed all components to assemble as expected.It is unclear if an s1 screw has loosened based on the images provided.The exact cause of the reported issue could not be determined.

Event Description

It was reported by a representative from japan that a revision surgery was done to remove and replace the l5 locking cap and s1 screw have loosened post-operatively.

• Brand Name: CREO
• Type of Device: CREO MIS LOCKING CAP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10804548
• MDR Text Key: 216943281
• Report Number: 3004142400-2020-00145
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (y/n): N
• PMA/PMN Number: K124058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAX133UB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR