MAUDE Adverse Event Report: STRYKER-SPINE YUKON OCT SPINAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/08/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a screw backed-out, loosened or disengaged 7 months post -operatively.Patient was revised (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject implants were not available for evaluation, and the specific product information could not be confirmed.The incident was confirmed through evaluation of post-operative x-rays, wherein it appears that the four screws placed at the c7 and t1 levels were disengaged from the bone.The patient was revised, the subject screws were removed and replaced, and the construct was extended to c2.

Event Description

On (b)(6) 2018 it was reported to k2m, inc, that polyaxial screws pulled out approximately seven months post-operatively.

• Brand Name: YUKON OCT SPINAL SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8380727
• MDR Text Key: 137509147
• Report Number: 3004774118-2019-00017
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 85