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

Catalog Number	7770728
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2017, intra-op, after preparation of disc space when the spacer was being inserted into disc space,upon impaction the peek portion of the spacer fractured at the back of the spacer.Two small fragments broke off.The product was explanted completely.There were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
Product analysis: visual review of the implant confirmed the ¿ears of the -03 top component deformed and broken.Microscopic examination of the -03 peek top component scalloped features did identify and witness marks, suggesting possible physical obstruction during attempted implantation which prevented full insertion into the vertebral disc space.Visual, optical and microscopic examination of the front-facing tab on the -03 peek top component did not identify witness marks or deformation consistent with angulation during attempted assembly.The above observations are consistent with implant fracture due to brittle overload during attempted implantation.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: 6864168
• Report Number: 1030489-2017-02039
• Device Sequence Number: 16172136
• Product Code: MAX
• UDI-Device Identifier: 00643169430655
• UDI-Public: 00643169430655
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: 08/02/2024
• Device Catalogue Number: 7770728
• Device Lot Number: 0503459W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR