MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 3.5X14 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-03514
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital did not return device.
Event or Problem Description
A physician reported that a yukon polyaxial screw became ¿stuck¿ at the head postoperatively.Following implant surgery, the patient did not wear their cervical collar as directed by the physician and, ¿went back to regular activities before they were advised to.¿ the patient was revised and lamina screws c3 through c6 were replaced.Patient was revised and all lamina screws c3-c6 were replaced.
Event or Problem Description
A physician reported that a yukon polyaxial screw became ¿stuck¿ at the head postoperatively.Following implant surgery, the patient did not wear their cervical collar as directed by the physician and, ¿went back to regular activities before they were advised to.¿ the patient was revised and lamina screws c3 through c6 were replaced.
Additional Manufacturer Narrative
Correction: updated from 'stryker spine- leesburg' to 'k2m, inc.' visual, functional, dimensional, and material analysis could not be performed as the device was not returned.However, photos of the screw and x-rays were provided by the rep.Upon review, it was observed that the screw housing was tilted at an angle.X-rays revealed that the subject screw slipped axially along the rod at the cephalic end of the construct.There appears to be minimal overhang length at the end of the construct.Device and complaint history records were reviewed for the provided lot number and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: postoperative- adequately instruct the patient.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.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 post-operatively 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.Surgical implants must never be reused.An explanted metal implant should never be reimplanted.Even though the device appears undamaged, it may have small imperfections and internal stress patterns which may lead to early breakage.The patient did not wear the collar and resumed back to regular activities before being advised to.Load bearing motions and activity levels may have caused the rod to slip out of the screw.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices.Additionally, minimal overhang length at the end of the construct may have contributed to the failure.

• Brand Name: POLYAXIAL SCREW; SIZE 3.5X14 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8857535
• Report Number: 3004774118-2019-00075
• Device Sequence Number: 1904464
• Product Code: NKG
• UDI-Device Identifier: 10888857349315
• UDI-Public: 10888857349315
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 7601-03514
• Device Lot Number: GJPR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1