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

Lot Number NZ14180083

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

Method: graft was not returned to rti for evaluation, therefore a re-review was performed of the manufacturing records, sterilization run reports, environmental monitoring results, quality control / assurance reviews and release, and the complaint database for related complaints associated with the lot.Results: no deviations were noted during processing for lot nz14180083.The graft underwent a validated sterilization methodology; tutoplast® which includes terminal sterilization by gamma irradiation after packaging.Environmental data and records generated during and around the time of processing for the lot were acceptable.To date, rti has distributed 21 xenografts from this lot without related complaints.Conclusion: the device was not returned for evaluation.Records re-review results demonstrated no deviations during the manufacturing of graft id (b)(4) and it met all specification requirements and release criteria at the time of distribution.No related complaints were noted associated with this lot.Additional information was requested regarding the initial procedure, sutures utilized, the appearance of the graft during the second intervention prior to re-suturing, and whether the patient is or not allergic to material of bovine origin.To date, rti has not received additional information.Based on our records re-review and the information provided, this event is unlikely related to the xenograft implant.Device was not returned for evaluation.

Event Description

Rti surgical, inc.(rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti, received a complaint on (b)(4) 2016 indicating that the surgeon implanted and integra bovine pericardium dural graft in a patient with chiari malformation on (b)(6) 2016.The patient returned for follow up on (b)(6) 2016 and had developed a cone in the back of her head from cerebrospinal fluid leakage.The surgeon tried to resuture the bovine pericardium back in place and it shredded.To date, rti has not received additional information.

• 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: 5444470
• MDR Text Key: 38462837
• Report Number: 3002719998-2016-00004
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Lot Number: NZ14180083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• 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