MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ALTERA; ALTERA INSERTER SLEEVE

Model Number	6124.0002
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to insert an altera cage met resistance and then a dural tear was observed and fixed intraoperatively.There are no known side effects after surgery.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows minor deformation on the distal medial tip of the instrument.This deformation can occur when the gold knob on the inserter base is excessively tightened.An exact cause of the reported issue could not be determined.

• Brand Name: ALTERA
• Common Device Name: ALTERA INSERTER SLEEVE
• 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: 15392015
• Report Number: 3004142400-2022-00134
• Device Sequence Number: 17673073
• Product Code: LXH
• UDI-Device Identifier: 00889095174557
• UDI-Public: 00889095174557
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140411
• 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): 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6124.0002
• Device Lot Number: IDR322RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female