MAUDE Adverse Event Report: SYNTHES USA; DURA SUBSTITUTE

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthecel implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.(b)(4).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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a surgeon performed a hemi craniotomy after trauma.During this procedure the surgeon states that he lifted the scalp and the synthecel was adherent to the underlying structures (dura replacement, the dura and the raw brain); the surgeon reports no adherence issues.This was a planned reoperation for the patient's underlining disease process.The device remains in the patient.This report is for an unknown synthecel implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development evaluation was completed: the product was not returned for evaluation.However, the case was discussed with the surgeon who had performed the procedure.The surgeon placed the graft over the exposed brain as an on-lay.He would lay the corners of the synthecel over the bone at the margin.This allowed him to more easily find the layer of synthecel and start his dissection of the synthecel form the skin flap.After 4 months when he lifted up the scalp he discovered a nice plane between the scalp and the dura and he was able to very easily lift up the scalp with a bit of dissection, there was some adherence between the synthecel and scalp.The majority of the piece of synthecel was stuck on to the underlying dura and the brain, none of that lifted up.Device not explanted.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: DURA SUBSTITUTE
• 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: 5242257
• MDR Text Key: 31798471
• Report Number: 2520274-2015-17444
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention