MAUDE Adverse Event Report: LDR SPINE LRD SPINE; ANCHORING PLATE

Model Number MC - 1442 P

Device Problem Defective Component (2292)

Patient Problem No Code Available (3191)

Event Date 01/15/2013

Event Type  Injury  

Event Description

Pt called on (b)(6) 2014 to ask that we preserve the hardware which was to be removed on (b)(6) 2014.The hardware was originally placed on (b)(6) 2013.He felt that the hardware may have been defective.As a result, he will undergo another surgery to remove/ replace the hardware.We held the explanted hardware in the lab.On (b)(6) 2014, the pt called in for the results if available.The hardware will be released today on (b)(4) 2014 to the sales rep.: (b)(4).

• Brand Name: LRD SPINE
• Type of Device: ANCHORING PLATE
• Manufacturer (Section D): LDR SPINE; 13785 research blvd; austin TX
• MDR Report Key: 4387771
• MDR Text Key: 21726656
• Report Number: 4387771
• Device Sequence Number: 1
• Product Code: OVD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2017
• Device Model Number: MC - 1442 P
• Device Catalogue Number: MC - 1442 P
• Device Lot Number: 27009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2014
• Distributor Facility Aware Date: 10/21/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR