MAUDE Adverse Event Report: EXACTECH INC. OPTECURE WITH CCC; BONE VOID FILLER

Catalog Number 652-00-01

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/03/2014

Event Type  Other  

Event Description

At five months follow up, the surgeon reported that the results of a cbct showed no integration of the bone graft in patient.

Manufacturer Narrative

The contribution of the devices to the experience reported has not be determined as the devices have not been returned for evaluation.

• Brand Name: OPTECURE WITH CCC
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): EXACTECH INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653 ; 8003922832
• MDR Report Key: 3766844
• MDR Text Key: 4374031
• Report Number: 1038671-2014-00123
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 652-00-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2014
• 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): Other
• Patient Age: 63 YR
• Patient Weight: 75