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

Model Number	201-14016C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported via xray, post-operatively, that a pyrenees constrained self tapping screw broke.Revision surgery has not been scheduled or performed at this time.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.Initial surgery was performed on (b)(6) 2020 and revision surgery has not been performed to date.The construct spanned from c5-c6 and the fracture occurred at c5.No complications during the initial surgery was reported.Screw holes were prepared using a drill, screws were inserted using a screwdriver.Surgery was not performed at a difficult angle.Patient performed moderate exercise after the initial surgery and did not fall.Patient did not fuse.Patient's bone quality was reported to be good.The pyrenees surgical technique and device ifu were reviewed: "postoperative care and the patient¿s ability and willingness to follow instructions are two of the most important aspects of successful healing.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.Loads produced by load bearing and activity levels will impact the longevity of the implant".Since the device was not returned, an exact cause of the reported event could not be determined.Potential causes include: excess patient activity level, non fusion due to patient's bone quality and inadequate construct compression during initial surgery.
Event or Problem Description
It was reported via xray, post-operatively, that a pyrenees constrained self tapping screw broke.Revision surgery has not been scheduled or performed at this time.

• 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: 12425310
• Report Number: 3004774118-2021-00267
• Device Sequence Number: 14286005
• Product Code: KWQ
• UDI-Device Identifier: 10888857027022
• UDI-Public: 10888857027022
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 201-14016C
• Device Catalogue Number: 201-14016C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/20/2021
• 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
• Patient Sex: Female