MAUDE Adverse Event Report: K2M INC. PYRENEES CERVICAL PLATE SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/30/2019

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) 2019 it was reported to manufacturer that there was a screw back-out approximately 3 months post-operatively.Revision surgery took place (b)(6) 2019.

• Brand Name: PYRENEES CERVICAL PLATE SYSTEM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M. INC; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: eva james ; 600 hope parkway se; leesburg, VA 20175 ; 5719192080
• MDR Report Key: 8635411
• MDR Text Key: 145897845
• Report Number: 3004774118-2019-00054
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention