MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PYRAMESH C TITANIUM MESH; MESH, METAL

Catalog Number 905-137

Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Implanted date: only year valid.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 as per a litigation complaint that on an unknown date in 2013, the patient underwent a surgery due to cervical injury caused from an accident in the school.Allegedly, a cervical vertebra was surgically implanted.On an unknown date, post-op, the implant was found broken and loosened.No more information is available now.

• Brand Name: PYRAMESH C TITANIUM MESH
• Type of Device: MESH, 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9500883
• MDR Text Key: 181811900
• Report Number: 1030489-2019-01445
• Device Sequence Number: 1
• Product Code: EZX
• UDI-Device Identifier: 00673978080659
• UDI-Public: 00673978080659
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K011406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 905-137
• Device Lot Number: 0250974W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2013
• 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