MAUDE Adverse Event Report: EXACTECH, INC OPTECURE ALLOGRAFT, 5CC

Catalog Number 650-00-05

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

Patient Problem Pain (1994)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

Pending engineering evaluation.

Event Description

Patient contacted exactech via e-mail complaining of pain in her right shoulder after a rtsr on (b)(6) 2008.

Manufacturer Narrative

Engineering evaluation noted that the identified unit met all requirements and was acceptable for transplant.

Event Description

Patient contacted exactech via e-mail complaining of pain in her right shoulder after a rtsr on (b)(6) 2008.

• Brand Name: OPTECURE ALLOGRAFT, 5CC
• Type of Device: ALLOGRAFT
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 5220927
• MDR Text Key: 31094873
• Report Number: 1038671-2015-00659
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 650-00-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention