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

Model Number	905-403
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: MESH, METAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10783419
• Report Number: 1030489-2020-01581
• Device Sequence Number: 19766294
• Product Code: EZX
• UDI-Device Identifier: 00673978080895
• UDI-Public: 00673978080895
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 905-403
• Device Catalogue Number: 905-403
• Device Lot Number: 0707556W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR