MAUDE Adverse Event Report: EXACTECH, INC. ACAPELLA LORDOTIC SPACER, 6MM

Catalog Number 05-090-01-1406

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

During a follow-up visit, it was observed that the caudal anchor had backed out anteriorly.The spacer had not moved and the cephalad anchor appeared to still be locked in place.Intraoperative fluoroscopy image showed anchor deployment.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

• Brand Name: ACAPELLA LORDOTIC SPACER, 6MM
• Type of Device: SPACER
• Manufacturer (Section D): EXACTECH, INC.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4875945
• MDR Text Key: 6260609
• Report Number: 1038671-2015-00290
• Device Sequence Number: 1
• Product Code: OVE
• 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: 06/25/2015

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: Health Professional
• Device Catalogue Number: 05-090-01-1406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/26/2015
• 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