MAUDE Adverse Event Report: K2M, INC. CONSTRAINED PLATE, 3 LEVEL; SIZE 57 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	208-43F57
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported experiencing pain and imaging indicated two pyrenees self-tapping screws had backed out.The patient was revised and, during the revision surgery, the surgeon additionally noted that the pyrenees plate was fractured.This report captures the fractured plate.
Additional Manufacturer Narrative
Hospital discarded device.
Event or Problem Description
A patient reported experiencing pain and imaging indicated two pyrenees self-tapping screws had backed out.The patient was revised and, during the revision surgery, the surgeon additionally noted that the pyrenees plate was fractured.This report captures the fractured plate.
Additional Manufacturer Narrative
H6: coding has been updated to reflect completion of the investigation.

• Brand Name: CONSTRAINED PLATE, 3 LEVEL; SIZE 57 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16820696
• Report Number: 3004774118-2023-00047
• Device Sequence Number: 7014327
• Product Code: KWQ
• UDI-Device Identifier: 10888857031166
• UDI-Public: 10888857031166
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 208-43F57
• Device Catalogue Number: 208-43F57
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown