MAUDE Adverse Event Report: LDR MEDICAL LDR SPINE ROI-C INTERBODY FUSION DEVICE; CERVICAL INTERBODY FUSION DEVICE

Model Number MC1006T, MC1444P

Device Problem Malposition of Device (2616)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Revision surgery to remove implant due to pt having dysphagia and some pain following initial surgery.

• Brand Name: LDR SPINE ROI-C INTERBODY FUSION DEVICE
• Type of Device: CERVICAL INTERBODY FUSION DEVICE
• Manufacturer (Section D): LDR MEDICAL; rosieres-pres-troyes ; FR
• Manufacturer (Section G): LDR SPINE USA; 4030 west braker lane; suite 360; austin TX 78759
• Manufacturer Contact: 4030 west braker lane; suite 360; austin, TX 78759
• MDR Report Key: 4039886
• MDR Text Key: 4902118
• Report Number: 3004903783-2014-00014
• Device Sequence Number: 1
• Product Code: ODP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: MC1006T, MC1444P
• Device Lot Number: 600469, 33802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2014
• Distributor Facility Aware Date: 06/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR