MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH; PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL

Model Number G8292035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via manufacturing representative regarding patient with lumbar spinal canal stenosis suggested for spinal therapy.Levels implanted: l5/6.It was reported adjacent segment disease occurred after fixation.Screw was removed and intervertebral fusion was performed on one intervertebral disc on the cranial side.Explant is planned.((b)(6) 2020) patient outcome and symptoms are unknown.No further complications reported.Update: 2020-aug-27; the sales rep didn't hear of any malfunctions in the implant.It was heard that symptom occurred on the cranial side of the fixed in tervertebral space.Tlif on one intervertebral disc was scheduled to be performed on cranial adjacent segment of the fixed intervertebral space.

• Brand Name: TSRH
• Type of Device: PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10498578
• MDR Text Key: 206102143
• Report Number: 1030489-2020-01198
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G8292035
• Device Catalogue Number: G8292035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• 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