MAUDE Adverse Event Report: K2M, INC. BLUE RIDGE CERVICAL PLATE

Catalog Number 3914-41F30

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 12/10/2013

Event Type  Injury  

Event Description

Bilateral blue ridge screws backed out of a 4-level plate approximately three months post-operatively.The patient did not warrant revision until approximately 11 months post-operatively.

Manufacturer Narrative

The screws had begun to back out approximately 3 months post-op however, the patient was asymptomatic and did not warrant revision until approximately 11 months post-operatively.The patient was revised with another product and the blue ridge plate and screws (3914-41f30 and 3901-04014c) were inadvertently discarded and are unavailable for evaluation.The representative did indicate that all clips were intact.The lot numbers of the plate and screws were also not made available however, a general review of overall manufacturing records for this system has been performed and no manufacturing or material discrepancies have been found.Without the actual device or x-rays, no firm conclusions can be drawn as to the root cause of the screw back-out.A company representative met with the surgeon when the back-outs were initially reported and the surgical technique was reviewed and efforts were made to try to determine what may have contributed to the event.We will continue to monitor issues of this nature.Device not returned.

• Brand Name: BLUE RIDGE CERVICAL PLATE
• Type of Device: CERVICAL PLATE
• Manufacturer (Section D): K2M, INC.; 751 miller dr. se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 751 miller dr. se; leesburg VA 20175
• Manufacturer Contact: rich woods ; 751 miller drive se; leesburg, VA 20175 ; 7037773155
• MDR Report Key: 3567513
• MDR Text Key: 19695087
• Report Number: 3004774118-2014-00004
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K113328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 3914-41F30
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2013
• 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