MAUDE Adverse Event Report: K2M INC. OZARK CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 8801-04018DA

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 03/05/2019

Event Type  Injury  

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 03.04.2019 it was reported to k2m, inc.That two screws broke approximately 3 months post-operatively.The patient was revised on (b)(6) 2019.The shafts of both of the broken screws remain in the patient.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That two screws broke approximately 2 months post-operatively.The patient was revixed on (b)(6) 2019.The shafts of both of the broken screws remain in the patient.

Manufacturer Narrative

It was reported that two ozark variable screws, implanted at the most caudal level of a 3-level ozark guide cervical plate, spanning c4-c7, were fractured approximately two months post-operatively.The patient was revised, and the screws were removed along with the plate, which reportedly presented damage to the screw cover at the c7 level.The distal ends of the screws remain in the patient, and the explanted hardware was not available for evaluation.The incident was confirmed through analysis of associated radiographic images.A root cause was unable to be determined, however the location of the fracture and surrounding hardware suggests that slight migration of the construct post-operatively may have contributed to the failure.

• Brand Name: OZARK CERVICAL PLATE SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8438352
• MDR Text Key: 139384635
• Report Number: 3004774118-2019-00031
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8801-04018DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 100