MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CLYDESDALE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 2968850

Device Problem Malposition of Device (2616)

Patient Problems Neuropathy (1983); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Event date is approximate: (b)(6) 2016.Neither the product nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent oblique lumbar interbody fusion surgery with at l3/4/5 levels due to degenerative scoliosis.The cage which was to be placed at l4/5 had been placed in the rear so compression of the contra-lateral nerve root was expected.Post-op, l4/5 radiculopathy was observed in the patient.Posterior decompression surgery scheduled on (b)(6) 2016.

• Brand Name: CLYDESDALE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5607939
• MDR Text Key: 43637287
• Report Number: 1030489-2016-01190
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2023
• Device Catalogue Number: 2968850
• Device Lot Number: H5225207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2015
• 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): Required Intervention