MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; MODULAR HEAD - OPEN LATERAL CONNECTOR, 5.5-6.35

Model Number	1175.6255
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation, however images of the concerned parts were available.It was noted by that the connector was unable to be secured to an existing cocr rod.The set screw was replaced from another connector and the connector was still unable to be secured to the existing rod.From the provided images, the connector was placed at l2/l3.It was noticed that the tip of all set screws had excessive wear/deformation and appeared to have wear on the threads.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a revision, the surgeon had difficulty locking a creo addition open lateral connector to a rod, and delayed the case by 1 and a half hours.This event occurred in japan. .
Additional Manufacturer Narrative
The device was available for evaluation.Four parts were returned for evaluation, 1175.6255, 1175.5529, and 1175.6355 (2x).Upon initial evaluation it was noticed the rod was scratched on the 1175.5529 (lateral headed rod, left), consistent with contouring and insertion/removal of the rod.The anodize within the holding slots was also worn, consistent with connection to the inserter and use.As received, the set screw was also not in the pre-assembled "up" position, which would prevent the connector from being able to be connected to the 1175.6255 (modular head-open lateral connector) or 1175.6355 (modular head-open superior connector).The set screw hex showed signs of use.The set screw was able to be threaded counter-clockwise into the pre-assembled "up" position.On the 1175.6255 (modular head-open lateral connector), wear on the spherical head was seen, consistent with use and possible locking of the headed rod onto the connector.The rod slot showed clear signs of a rod being final tightened into the connector.The rod set screw showed deformation around the distal edge, consistent with locking to a rod, and showed deformation of the hexalobe.Two 1175.6355 (modular head-open superior connector) were returned.The rod set screw on both showed deformation around the distal edge, consistent with locking to a rod, and showed deformation of the hexalobe.Only one connector body showed signs of use, with deformation in the rod slot from tightening to a rod, and some wear on the spherical head from insertion.The other connector did not appear to be used, aside from the set screw, consistent with the complaint description of using the set screw from another connector.The 1175.6255 (modular head-open lateral connector) and 2x 1175.6355 (modular head-open superior connector) rod set screws were able to move clockwise and counter-clockwise, but the connectors were able to rotate around the rod after final tightening when torque was applied to the connector.The rod set screws on these connectors had all been previously final tightened to a cocr rod, so no conclusions can be made from the failed functional tests.The x-ray images provided show another 1175.6255 (modular head-open lateral connector) and lateral headed rod were used on the other side of the construct without issues.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a revision, the surgeon had difficulty locking a creo addition open lateral connector to a rod, and delayed the case by 1 and a half hours.This event occurred in japan. .

• Brand Name: CREO
• Common Device Name: MODULAR HEAD - OPEN LATERAL CONNECTOR, 5.5-6.35
• 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: 19059920
• Report Number: 3004142400-2024-00063
• Device Sequence Number: 6030254
• Product Code: NKB
• UDI-Device Identifier: 00889095483420
• UDI-Public: 00889095483420
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180210
• 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,Followup
• Report Date (Section B): 05/24/2024

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: 1175.6255
• Device Lot Number: JNB419YB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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 Sex: Female
• Patient Race: Asian