MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number GX83575459

Device Problem Migration (4003)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the us, however a like device with part# 83565459, 510k# k090740 and upn (b)(4) is approved for sale.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent decompression at l4/5 and performed fixation to l3-5 due to stenosis.Post-op, neurological symptom occurred on the right of l5.When the patient moved, there was feeling of palsy.The implanted screw deviated and compressed the nerve.Revision surgery was performed and direction of the screw on the right of l5 was adjusted.

• Brand Name: TSRH SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8393863
• MDR Text Key: 137928743
• Report Number: 1030489-2019-00233
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2019

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 Catalogue Number: GX83575459
• Device Lot Number: 0579341W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2017
• 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): Other; Required Intervention
• Patient Age: 66 YR