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	05/05/2017
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.
Event or Problem Description
It was reported that during surgery, the interbody device broke into two pieces upon insertion.No fragments remain in the patient.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
Visual, optical and microscopic examination of the returned implant identified witness marks on the posterior vertical surface, suggesting direct impact on the rear of the -01 base component.The ¿ears¿ of the -03 component are bent and cracked on one side and broken off on the other side, with the broken-off portion not returned for analysis, with the interior of the portion of the sidewalls deformed, consistent with significant impact.The vertical post of the -07 peek component is also broken off with remaining material deformation and fracture surface indicative of a torsional component.The above observations are consistent with significant impact during attempted insertion.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6597221
• Report Number: 1030489-2017-01377
• Device Sequence Number: 1149020
• Product Code: MAX
• UDI-Device Identifier: 00643169430655
• UDI-Public: 00643169430655
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2017

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: 05/16/2024
• Device Catalogue Number: 7770728
• Device Lot Number: 0480361W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 08/28/2017; 08/28/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/29/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR