MAUDE Adverse Event Report: SYNTHES USA 4.0MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 450.136

Device Problem Fitting Problem (2183)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2014

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.Surgery was scheduled for the posterior portion.At the start of 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).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.This report is 2 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: 4.0MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 16MM
• 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: 3905220
• MDR Text Key: 17291406
• Report Number: 2520274-2014-12203
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031276
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 450.136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 44 YR