MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SP-FIX; SP-FIX SCREW

Model Number	188.044
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient's spinous process broke post-operatively.Subsequently, sp-fix implant has migrated.This event occurred in germany.
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a patient's spinous process broke post-operatively.Subsequently, sp-fix implant has migrated.This event occurred in germany.
Additional Manufacturer Narrative
The peek barrel was returned, connected to two plates.Additional information provided that the surgeon believes he may have used a barrel too large for the patient's anatomy.It is possible that the used of incorrect barrel size in conjunction with poor bone quality may have caused the spinous to break off.

• Brand Name: SP-FIX
• Common Device Name: SP-FIX SCREW
• 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: 14689188
• Report Number: 3004142400-2022-00100
• Device Sequence Number: 20098151
• Product Code: KWP
• UDI-Device Identifier: 00849044091649
• UDI-Public: 00849044091649
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/13/2022

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: 188.044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Sex: Male