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

Model Number	8880823
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10243729
• Report Number: 1030489-2020-00855
• Device Sequence Number: 16292316
• Product Code: MAX
• UDI-Device Identifier: 00643169430778
• UDI-Public: 00643169430778
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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 Expiration Date: 12/19/2023
• Device Model Number: 8880823
• Device Catalogue Number: 8880823
• Device Lot Number: 0443479W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 102