MAUDE Adverse Event Report: K2M, INC. SCREW; SIZE Ø6.0X28 MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	1201-16028
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that during a routine post-op follow-up x-ray, the surgeon noted a cayman screw backed out.The screw remains implanted in the patient.Revision surgery is not planned at this time.This record represents 2 of 2 screws.
Additional Manufacturer Narrative
Correction: updated from 'stryker spine- leesburg' to 'k2m, inc.' visual, dimensional, material and functional analysis could not be performed as the device was not returned.Lateral x-rays were supplied and review of post-operative x-rays indicate that two screws had backed out of a cayman anterior lumbar plate.It was observed that the screw shafts had shifted in the caudal direction.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: 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.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.It appears the vertebral body at l2, where the subject screws were implanted, shifted caudally, causing the subject screws to also shift.Lateral x-rays also revealed that a cage was positioned at l3-l4.It is possible that lack of posterior fixation lead to residual motion within the construct and caused the vertebral body to subside.
Event or Problem Description
It was reported that during a routine post-op follow-up x-ray, the surgeon noted a cayman screw backed out.The screw remains implanted in the patient.Revision surgery is not planned at this time.This record represents 2 of 2 screws.

• Brand Name: SCREW; SIZE Ø6.0X28 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8803824
• Report Number: 3004774118-2019-00070
• Device Sequence Number: 16817643
• Product Code: KWQ
• UDI-Device Identifier: 10888857018617
• UDI-Public: 10888857018617
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K081380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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 Catalogue Number: 1201-16028
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1