MAUDE Adverse Event Report: LDR MEDICAL IMPLANT ROI-C LORDOSE; LDR SPINE ROI-C CERVICAL CAGE SYSTEM

Catalog Number MC1444P

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Paraplegia (2448); Quadriplegia (2449)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4) - ldr spine usa, inc.(importer) is submitting the report on behalf of ldr medical (manufacturer).(b)(4).Other: distributor (b)(4).Follow-up with cdrh dt support team on (b)(6) 2020 determined this submission could not be located, so it is being resubmitted.The correspondance is attach in an email to this report.

Event Description

At final fluoro, marker appeared too posterior.Surgeon removed cage and plates and completed case with a competitor construct.Patient woke with paraplegia.

Event Description

At final flouro, marker appeared too posterior.Surgeon removed cage and plates and completed case with a competitor's construct.Patient woke with paraplegia.New information was received reporting that the patient was transferred to the intensive care unit (icu) post-op where he was given steroids for eight days.The patient was diagnosed with incomplete quadraplegia with lower extremity weakness and loss of lower extremity motor and sensory functions.It was also reported the patient has post-op right hand and shoulder, left shoulder, left hip and low back pain that requires medication.

Manufacturer Narrative

The additionally provided information does not impact the previously reported method, result, or conclusion codes as the device evaluation has not altered.

• Brand Name: IMPLANT ROI-C LORDOSE
• Type of Device: LDR SPINE ROI-C CERVICAL CAGE SYSTEM
• Manufacturer (Section D): LDR MEDICAL; see h10; see h10; sainte-savine 10300 ; FR 10300
• MDR Report Key: 9888934
• MDR Text Key: 187559374
• Report Number: 3004903783-2017-00009
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• PMA/PMN Number: K150765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: MC1444P
• Device Lot Number: 45841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/03/2017
• Device Age: 12 MO
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 30 YR
• Patient Weight: 109