MAUDE Adverse Event Report: SPINESMITH PARTNERS L.P. IN:C2 SPINAL FIXATION SYSTEM; INTERVERTEBRAL FUSION DEVICE

Model Number 1102-0080

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2013

Event Type  malfunction  

Manufacturer Narrative

No dimensional discrepancies were identified and all material and processing certifications were to specification.Visual evaluation of the returned peek component identified that the snap features were damaged and there was a blind hole drilled in the back of the implant.There were forcep marks in several locations of the peek including along the damaged snap feature areas.It is not known if the snap feature was damaged by the forceps during removal or during initial insertion.From surgeon description, he had several problems with angling the construct in place and the trajectory of the drilled hole indicates that the drill guides and plate holder were not at the correct angles to the patient's vertebral endplates.The description of the difficulty in viewing the construct due to the patient's shoulders in addition to the angles of the drilled hole suggest patient anatomy was interfering with proper positioning of the construct but no definitive conclusion can be made.This is the first report of this type with the in:c2 system and will be monitored for future occurrences.Note:.

Event Description

While attempting to insert an in: c2 zero profile plate and peek component, the plate and peek component dissociated twice.Eventually the surgeon was able to implant the construct but was not happy with the position or the visualization due to patient anatomy where the shoulders were obscuring the implant markers.He felt that the final construct was too deep and decided to use a different plate system.

• Brand Name: IN:C2 SPINAL FIXATION SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): SPINESMITH PARTNERS L.P.
• Manufacturer Contact: clifton (chris) naivar ; 93 red river; austin, TX 78701 ; 5126372068
• MDR Report Key: 3646952
• MDR Text Key: 49026739
• Report Number: 3006404071-2014-00001
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1102-0080
• Device Lot Number: PPAS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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): Other