MAUDE Adverse Event Report: STRYKER-SPINE OZARK CERVICAL PLATE; APPLIANCE, FIXATION SPINL INTERVETEBRAL BODY

Catalog Number 8801-04016CA

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.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 surgery took place in which two screw broke approximately 4-6 months post-operatively.The two screws remain in the patient.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The screws were placed bilaterally at the most caudal level of a two-level ozark view anterior cervical plate, spanning levels c5 to c7.The implants remain in the patient and were not available for evaluation.The failure was confirmed through visual analysis of the x-rays.Although a root cause could not be determined, the location of the fracture and trajectory of the screws indicate post-operative migration of the screws coupled with a potential settling of the supplemental interbody spacer may have resulted in a similar failure.

Event Description

On (b)(6) 2019 it was reported that a surgery took place in which two screws broke approximately 4-6 months post-operatively.Two screws remain in the patient.

• Brand Name: OZARK CERVICAL PLATE
• Type of Device: APPLIANCE, FIXATION SPINL INTERVETEBRAL BODY
• Manufacturer (Section D): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8616622
• MDR Text Key: 145278057
• Report Number: 3004774118-2019-00053
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K172104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8801-04016CA
• Device Lot Number: YYBF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1