MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. HEDRON IA PLATE/SPACER; HEDRON IA SPACER, 26X34, 13MM, 15°

Model Number	1212.0713S
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part was not available for evaluation.Additional information provided states that there is a possibility that the blocking screw was struck by the anchor impactor during this secondary impaction and compromised the blocking screw.However, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a hedron anchor is backing out 2 weeks post operatively.

• Brand Name: HEDRON IA PLATE/SPACER
• Common Device Name: HEDRON IA SPACER, 26X34, 13MM, 15°
• 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 ; 6109301822
• MDR Report Key: 13117299
• Report Number: 3004142400-2021-00238
• Device Sequence Number: 17219569
• Product Code: MAX
• UDI-Device Identifier: 00193982191597
• UDI-Public: 00193982191597
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D357370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/16/2021

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: 1212.0713S
• Device Lot Number: GBY332XF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2021
• 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