MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-16 for COPIOS CANCELLOUS XENOGRAFT PARTICLES manufactured by Rti Surgical.
[47595396]
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.
Patient Sequence No: 1, Text Type: N, H10
[47595397]
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.
Patient Sequence No: 1, Text Type: D, B5
[48953309]
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
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002924436-2016-00002 |
| MDR Report Key | 5729750 |
| Date Received | 2016-06-16 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-05-20 |
| Device Manufacturer Date | 2014-04-30 |
| Date Added to Maude | 2016-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS CHARITY EMMONS |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 3864188888 |
| Manufacturer G1 | RTI SURGICAL |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPIOS CANCELLOUS XENOGRAFT PARTICLES |
| Generic Name | XENOGRAFT CANCELLOUS PARTICLES |
| Product Code | NPM |
| Date Received | 2016-06-16 |
| Lot Number | NZ-210-01-02-12 |
| Device Expiration Date | 2019-03-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RTI SURGICAL |
| Manufacturer Address | 11621 RESEARCH CIRCLE ALACHUA FL 32615 US 32615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-16 |