MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE 4.5X40 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04540M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
A physician reported that two yukon polyaxial screws implanted at s2, "snapped just below the tulip head of the screws." the patient has been revised.This report represents the second of the two yukon polyaxial screws.
Event or Problem Description
A physician reported that two yukon polyaxial screws implanted at s2, "snapped just below the tulip head of the screws." the patient has been scheduled for revision surgery.This report represents the second of the two yukon polyaxial screws.
Event or Problem Description
A physician reported that two yukon polyaxial screws implanted at s2, "snapped just below the tulip head of the screws." the patient has been scheduled for revision surgery.This report represents the second of the two yukon polyaxial screws.
Additional Manufacturer Narrative
The device remains implanted in the patient so evaluation can not be performed.Manufacturing records could not be reviewed as no lot number was provided.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.The patient was approximately two-years old at the time of initial surgery and no complications were reported during the initial surgery.Per email correspondence, the patient is a very active young child and, "would wiggle around a lot." internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.The most likely root cause of reported event is high activity level of patient.

• Brand Name: POLYAXIAL SCREW ML; SIZE 4.5X40 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11269864
• Report Number: 3004774118-2021-00029
• Device Sequence Number: 17073920
• Product Code: NKG
• UDI-Device Identifier: 10888857351691
• UDI-Public: 10888857351691
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2021

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: 7601-04540M
• Device Catalogue Number: 7601-04540M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/03/2021; 04/30/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/26/2021; 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR