MAUDE Adverse Event Report: RTI SURGICAL COPIOS CANCELLOUS XENOGRAFT PARTICLES; XENOGRAFT CANCELLOUS PARTICLES

Lot Number NZ-210-01-02-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

Method: the graft was not returned 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 complaints database for related complaints associated with the lot.Results: there was one deviation noted for lot nz-210-01.02.12 related to instrumentation during receipt of bovine tissue.After investigation it was determined there was no risk associated to tissue and the tissue was approved for further processing.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 this lot were acceptable.To date rti has distributed 61 xenografts from this lot without related complaints for the lot.Conclusion: given the facts that: the device was not returned for evaluation; records review demonstrated no deviations that had a negative impact during manufacturing of graft id (b)(6); 3) the graft met specification requirements and release criteria at the time of distribution; and 4) no related complaints were noted associated with the distributed graft from this lot, it is unlikely that this event is related to the xenograft.

Event Description

Rti surgical, inc (rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti, received a report from the (b)(6) authority directly from the customer that an infection was noted.No other details were provided.

Manufacturer Narrative

Report submitted 06/16/16 in error.Copios cancellous xenograft particles are distributed rest of world and (b)(4) does not distribute the same or similar products in the united states, therefore, no reporting is required.

• Brand Name: COPIOS CANCELLOUS XENOGRAFT PARTICLES
• Type of Device: XENOGRAFT CANCELLOUS PARTICLES
• Manufacturer (Section D): RTI SURGICAL; 11621 research circle; alachua FL 32615
• Manufacturer (Section G): RTI SURGICAL; 11621 research circle; alachua FL 32615
• Manufacturer Contact: charity emmons ; 11621 research circle; alachua 32615 ; 3864188888
• MDR Report Key: 5729750
• MDR Text Key: 47595396
• Report Number: 3002924436-2016-00002
• Device Sequence Number: 1
• Product Code: NPM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Lot Number: NZ-210-01-02-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other