MAUDE Adverse Event Report: SYNTHES USA TI ANTERIOR CERVICAL COMPRESSION PL 2 LEVEL/43MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 450.516

Device Problem Fitting Problem (2183)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2014

Event Type  malfunction  

Event Description

It was reported that the original implant procedure, anterior cervical discectomy and fusion involving c4-c7, was performed on (b)(6) 2014.The planned second surgery was scheduled on (b)(6) 2014 for the posterior portion.At the start of the planned second surgery, upon intraoperative imaging for the posterior plate placement, it was observed by the surgeon that the anterior plate's cannulated-self locking screw, located at c4, went through the plate; the screw did not stop and lock into the anterior plate (the screw went in further into the plate).It was also reported that the surgeon decided to leave the anterior plate/screw as is.The posterior surgery was completed successfully with no report of harm to the patient and no delay in surgery.The plate and screw remain implanted in the patient.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI ANTERIOR CERVICAL COMPRESSION PL 2 LEVEL/43MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3900437
• MDR Text Key: 4654147
• Report Number: 2520274-2014-12201
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 450.516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Age: 44 YR