MAUDE Adverse Event Report: EXACTECH, INC ACAPELLE ONE SPACER

Device Problem Malposition of Device (2616)

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

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

Pending engineering evaluation.

Event Description

At a follow-up appointment two weeks after surgery, x-rays showed that two anchors had backed out in one cage, and one anchor had backed out in the second cage.

Manufacturer Narrative

Engineering evaluation noted that the backed out anchors reported were likely the result of the anchors not being fully locked at the time of implantation.

Event Description

At a follow-up appointment two weeks after surgery, x-rays showed that two anchors had backed out in one cage, and one anchor had backed out in the second cage.

• Brand Name: ACAPELLE ONE SPACER
• Type of Device: SPACER
• 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: 5111840
• MDR Text Key: 27141604
• Report Number: 1038671-2015-00526
• Device Sequence Number: 1
• Product Code: OVE
• 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: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• 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): Other