MAUDE Adverse Event Report: RTI SURGICAL, INC INTEGRA BOVINE PERICARDIUM DURAL GRAFT; SURGICAL MESH

Lot Number NOT PROVIDED

Device Problem Material Erosion (1214)

Patient Problem Skull Fracture (2077)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Product identifiers were not provided to rti in order to perform an investigation and re-review of manufacturing records.Device not returned for evaluation.

Event Description

Rti surgical, inc.(rti) and (b)(4), a wholly owned subsidiary of rti, received a complaint on (b)(6) 2016 indicating that the surgeon implanted an integra bovine pericardium dural graft.The surgeon believes he used dura seal as well.On an unknown date, the patient had fall and fractured his cranium shortly after placing the graft.Upon repairing the patient's new injuries, the surgeon noted that the graft appeared to erode from the middle out towards the suture lines.The surgeon could not say whether the fall had an impact on the graft failure or not.Rti has requested product identifiers and additional event details.To date, no additional information has been provided.

• Brand Name: INTEGRA BOVINE PERICARDIUM DURAL GRAFT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): RTI SURGICAL, INC; 11621 research circle; alachua FL 32615
• Manufacturer (Section G): RTI SURGICAL, INC; 11621 research circle; alachua FL 32615
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 5494776
• MDR Text Key: 40144794
• Report Number: 3002719998-2016-00007
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other