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

Model Number	1119.0010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace creo locking caps that became loose post operatively.
Additional Manufacturer Narrative
The devices were available for evaluation.It was reported that a revision was needed to replace creo locking caps that became loose post operatively on a l2-l5 construct.A revision was scheduled for the following thursday on (b)(6) 2024 where the rods and locking caps were replaced and a cross-connector was added to the construct.The x-rays that were provided showed a 5.5mm curved rod that had slipped out of the l5 screw on the left side extending proximally.In addition, the l2 left side locking cap and both l5 locking caps had loosened.Upon evaluation, 8 locking caps were returned with the following lot numbers: bab7abdd, bab80fgd,bab845kd, bab90cmd, bab920xd.It was found that 2 had an hour glass shape wear that is consistent with locking being achieved, and the other 4 had various degrees of wear seen on the bottom.The locking caps that were returned could not be correlated with any levels.The patient being obese may have contributed to the reported incident however, because the surgical conditions cannot be replicated, no determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: CREO THREADED LOCKING CAP
• 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: 19097397
• Report Number: 3004142400-2024-00065
• Device Sequence Number: 7408032
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/08/2024

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: 1119.0010
• Device Lot Number: BAB80FGD/BAB845KD/BAB920XD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male