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

Model Number 368.252

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 291399043
• Report Number: 3004142400-2022-00043
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00849044090734
• UDI-Public: 00849044090734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 368.252
• Device Lot Number: MKX128HG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other