MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ELEVATE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 7770832

Device Problem Crack (1135)

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

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent transforaminal lumbar interbody fusion (tlif) due to stenosis at l5/s1.Intra-op, the peek portion of the cage cracked upon insertion, before it advanced into the disc space.It was removed from the patient body.No patient symptoms or complications were reported as a result of this event.No additional surgery was performed as a result of this event.

• Brand Name: ELEVATE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 8734192
• MDR Text Key: 149194405
• Report Number: 1030489-2019-00664
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169430730
• UDI-Public: 00643169430730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7770832
• Device Lot Number: 0514650W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1