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

Catalog Number 905-800

Device Problem Break (1069)

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

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

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 presented with l3 tumor; and underwent l3 corpectomy and insertion of cage.Intra-op, when inserting the screw into the end plate in the cage, the screw head broke off the shaft.The shaft remains in the endplate, which is implanted in the patient.The screw head was explanted.No patient complications were reported as a result of this event.

• 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: 9597293
• MDR Text Key: 179254777
• Report Number: 1030489-2020-00077
• Device Sequence Number: 1
• Product Code: EZX
• UDI-Device Identifier: 20673978081148
• UDI-Public: 20673978081148
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011406
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 905-800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No
• 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