MAUDE Adverse Event Report: SYNTHES USA

Device Problem Device Slipped (1584)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

The patient underwent a zero-p removal revision surgery due to a possible non-union and a screw backing out.This was indicated by films taken.The original implant surgery was performed by a different surgeon on an unknown date.The revision surgeon removed a third party plate from the c4 to c7 segment and removed the zero-p device at level c3 and 4.The surgeon repeated the same fusion, re-plating, and allograft at the c3 and 4 level with a vectra plate as well as a posterior spinous process fusion of c3 and 4 using onlay graft and cable supplementation.There was no reported harm to the patient.The procedure was successfully completed.The zero-p implant was discarded, no part or lot numbers were documented.The revision was at c3 and 4 only.The zero-p was removed at c3 and 4 and the void replaced with bone graft and plated with vectra.The surgeon removed the third party manufactured plate at c4 to c7 prior to the removal of the zero-p implant.The segment from c4 to c7 had successfully fused.This report is for unknown spine part, the zero p implant involved in the non-union.This report is 2 of 3 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment not diagnosis.Investigation could not be completed and no conclusion could be drawn, as no device was returned and no part number or lot number was provided.Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA 1938 0
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3634042
• MDR Text Key: 16548479
• Report Number: 2520274-2014-00631
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/24/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84