MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-05-27 for CESPACE BONE CORT CAN 9X14X11.5MM LORDO ME649 manufactured by Contract Manufacturer: Rti Surgical.
[46162900]
Sales representative received sets containing expired allograft on (b)(6) 2016 for use in a case. The sets contained adequate product to complete the surgery as planned.
Patient Sequence No: 1, Text Type: D, B5
[71510752]
Review of documentation indicated that this issue was related to internal production of "sets" at aesculap inc. Corrective/preventive action was initiated at aesculap inc. To ensure this issue does not recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005673311-2016-00090 |
| MDR Report Key | 5686617 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-05-27 |
| Date of Report | 2017-03-23 |
| Date of Event | 2016-04-28 |
| Date Facility Aware | 2016-05-02 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2016-05-27 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | CONTRACT MANUFACTURER: 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 | CESPACE BONE CORT CAN 9X14X11.5MM LORDO |
| Generic Name | ALLOGRAFT |
| Product Code | JDN |
| Date Received | 2016-05-27 |
| Model Number | ME649 |
| Catalog Number | ME649 |
| Lot Number | 101086323 |
| Device Expiration Date | 2016-04-16 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTRACT MANUFACTURER: RTI SURGICAL |
| Manufacturer Address | 11621 RESEARCH CIRCLE ALACHUA FL 32615 US 32615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-27 |