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

Catalog Number	8880923
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with spinal stenosis and underwent transforaminal lumbar interbody fusion (tlif) surgery at l5-s1 levels.During surgery, the spacer broke during insertion.The product came in contact with the patient.No fragment of the spacer remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visually confirmed -03 peek upper component ears broken off and not returned for analysis.Microscopic examination did not identify damage to the nose of the -03 peek upper component.Implant as-received with -03 peek component raised slightly above the nose of the implant.Microscopic examination of the implant identified very light surface marks on the peek scallop features and deformation on one side of the nose of the -03 peek component, consistent with axial loading due to impingement of the -03 peek component during attempted intraoperative insertion and subsequent fracture of the implant.If information is provided in the future, a supplemental report will be issued.

• 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: 8036742
• Report Number: 1030489-2018-01444
• Device Sequence Number: 19148007
• Product Code: MAX
• UDI-Device Identifier: 00643169430785
• UDI-Public: 00643169430785
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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: 04/18/2026
• Device Catalogue Number: 8880923
• Device Lot Number: 0646802W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR