MAUDE Adverse Event Report: CONTRACT MANUFACTURER: RTI SURGICAL CESPACE BONE CORT CAN 9X14X11.5MM LORDO; ALLOGRAFT

Model Number ME649

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2016

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: CESPACE BONE CORT CAN 9X14X11.5MM LORDO
• Type of Device: ALLOGRAFT
• Manufacturer (Section D): CONTRACT MANUFACTURER: RTI SURGICAL; 11621 research circle; alachua FL 32615
• Manufacturer (Section G): CONTRACT MANUFACTURER: RTI SURGICAL; 11621 research circle; alachua FL 32615
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5686617
• MDR Text Key: 46162900
• Report Number: 3005673311-2016-00090
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/16/2016
• Device Model Number: ME649
• Device Catalogue Number: ME649
• Device Lot Number: 101086323
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/02/2016
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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