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

Model Number 8880823

Device Problem Break (1069)

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

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary #patient demographics- initials- (b)(6), gender- male, age (at the time of event)- (b)(6), weight- (b)(6) kg, medical history- spondylolisthesis, vp shunt, date of implant- (b)(6) 2020, date of explant- (b)(6) 2020, device status- explanted-complete.It was reported that on (b)(6) 2020, intra-op, the elevate cage fractured during implantation.There were no patient complications as a result of this event.Update received on 07 jul 2020: pre op diagnosis was spondylolisthesis and stenosis.Procedure was an l5-s1 minimally invasive transforaminal lumbar interbody fusion (mis tlif) no fragments left behind.510(k) no: k172199, k142559.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via manufacturing representative regarding patient with spondylolisthesis,vp shunt for spinal therapy.Patient demographics- initials- (b)(6), gender- male, age (at the time of event)- (b)(6), weight- (b)(6) kg, date of implant- (b)(6) 2020, date of explant- (b)(6) 2020, device status- explanted-complete.It was reported event occurred intra-op, the elevate cage fractured during implantation.There were no patient complications as a result of this event.Update received on 07 jul 2020: pre op diagnosis was spondylolisthesis and stenosis.Procedure was an l5-s1 minimally invasive transforaminal lumbar interbody fusion (mis tlif) no fragments left behind.

• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10243729
• MDR Text Key: 199289819
• Report Number: 1030489-2020-00855
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169430778
• UDI-Public: 00643169430778
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2023
• Device Model Number: 8880823
• Device Catalogue Number: 8880823
• Device Lot Number: 0443479W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2020
• Date Device Manufactured: 12/19/2015
• 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
• Patient Age: 71 YR
• Patient Weight: 102