MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	201-14016C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent revision surgery approximately three months post-operatively to address two fractured pyrenees constrained self-tapping screws at c7.This report captures the second of two pyrenees constrained self-tapping screws.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
A patient underwent revision surgery approximately three months post-operatively to address two fractured pyrenees constrained self-tapping screws at c7.This report captures the second of two pyrenees constrained self-tapping screws.

• Brand Name: SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 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: 18679118
• Report Number: 3004774118-2024-00007
• Device Sequence Number: 7217358
• Product Code: KWQ
• UDI-Device Identifier: 10888857027022
• UDI-Public: 10888857027022
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 06/13/2024

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 Catalogue Number: 201-14016C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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 Age: 40 YR
• Patient Sex: Female