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

Model Number 905-137

Device Problem Fracture (1260)

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

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

Report source: country: (b)(6).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

Information was received from a healthcare provider via manufacturer representative regarding a with an indication of spinal degeneration in need of spinal degeneration surgery used in spinal therapy.It was reported that the device has fractured during the surgery.There were no patient symptoms reported.There was no delay in overall procedure time.There were no fragments in the patient reported.There were no further complications reported regarding the 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10768811
• MDR Text Key: 214122221
• Report Number: 1030489-2020-01543
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 905-137
• Device Catalogue Number: 905-137
• Device Lot Number: 0575960W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2020
• Date Device Manufactured: 07/13/2017
• 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 Age: 51 YR