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

Model Number 905-403

Device Problem Fracture (1260)

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

Event Date 03/23/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturing representative regarding patient with lumbar degeneration suggested for lumbar degeneration surgery.Event occurred intra-op.It was reported that on (b)(6) 2019, hcp from the second affiliated hospital found the device damaged during patient's surgery, so hcp applied for replacement.Break was reported.No fragments in patient.No further symptoms or complications reported.Device was explanted.Update 2020-oct-20; there was titanium mesh fracture.

• 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: 10783419
• MDR Text Key: 214540924
• Report Number: 1030489-2020-01581
• Device Sequence Number: 1
• Product Code: EZX
• UDI-Device Identifier: 00673978080895
• UDI-Public: 00673978080895
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 905-403
• Device Catalogue Number: 905-403
• Device Lot Number: 0707556W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Date Device Manufactured: 02/18/2019
• 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: 45 YR