MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 3.5X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-03526
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported a yukon oct spinal system polyaxial screw; size ø3.5x26 mm pull out at c2 post-operatively.Revision surgery has occurred.
Event or Problem Description
Physician reported a yukon oct spinal system polyaxial screw pull out at c2 post-operatively.Revision surgery has occurred.
Additional Manufacturer Narrative
Corrected data: d.4.Lot number has been corrected from 3532/gyyj to gyyj.Visual inspection: the device appeared intact upon receipt.No deformations or abnormalities were observed.Upon review of x-rays, it was observed that a screw at the proximal end of the construct at level c2 pulled out of the vertebral body and was disengaged from its associated rod.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: postoperative.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.The implant was returned, visually and microscopically inspected.It is likely that non-union, coupled with unanticipated loading, contributed to the failure.According to the rep, fusion was not achieved.Per the yukon oct surgical technique, these 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.Post-operative patient activities may have introduced unanticipated loading within the construct, resulting in screw pullout.Dynamic movement from rod slippage may have also contributed to the failure.

• Brand Name: POLYAXIAL SCREW; SIZE 3.5X26 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9981262
• Report Number: 3004774118-2020-00074
• Device Sequence Number: 19807223
• Product Code: NKG
• UDI-Device Identifier: 10888857349377
• UDI-Public: 10888857349377
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 7601-03526
• Device Catalogue Number: 7601-03526
• Device Lot Number: GYYJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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: 59 YR
• Patient Weight: 87