MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PATRIOT SPACER SYSTEM; SIGNATURE TLIF SPACER, R SMALL, 12MM

Model Number	368.252
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.The imaging provided show the implant body fractured at the posterior portion during impaction.It is possible that the articulation stabilizer on the inserter was not fully retracted during impaction, or that the implant was not adequately parallel with the vertebral endplates during insertion causing an excess torsional load on the posterior portion of the implant.However, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that during the surgery a piece of the signature tlif spacer broke off from the holder and was left inside of the patient.This event occurred in (b)(6).
Event or Problem Description
It was reported that during the surgery a piece of the signature tlif spacer broke off from the holder and was left inside of the patient.This event occurred in poland.
Additional Manufacturer Narrative
The device was returned for evaluation.Observation shows the implant body is fractured at the posterior portion.The imaging provided show the implant body fractured at the posterior portion during impaction.It is possible that the articulation stabilizer on the inserter was not fully retracted during impaction, or that the implant was not adequately parallel with the vertebral endplates during insertion causing an excess torsional load on the posterior portion of the implant.However, the exact cause of the reported issue could not be determined.

• Brand Name: PATRIOT SPACER SYSTEM
• Common Device Name: SIGNATURE TLIF SPACER, R SMALL, 12MM
• 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: 13764637
• Report Number: 3004142400-2022-00043
• Device Sequence Number: 5198531
• Product Code: MAX
• UDI-Device Identifier: 00849044090734
• UDI-Public: 00849044090734
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122097
• 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): 05/06/2022

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: 368.252
• Device Lot Number: MKX128HG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• 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: Unknown