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

Catalog Number	8880823
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
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.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion (tlif) surgery at l5-s1 levels.Post-operatively, the spacer broke.The spacer was successfully explanted from the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: the body of the spacer is not fractured or broken.The screw used to expand the spacer has been damaged.Approximately 2mm is missing from the end of the screw.Because of damage to the surface after it broke, the direction and the area of the fracture propagation is difficult to determine but is consistent with torsional overload during the removal process.Witness marks and damage are also present on the back side of the spacer on both the titanium and peek portions that appear to be from the removal of the spacer.There should be no contact to these areas during installation.Witness marks also appear near the nose on the peek portion of the spacer that are consistent with typical installation.It was not possible to test the expanding feature of the spacer due to the amount of damage to the female torx.The screw could not be turned by hand.The screw does appear to be backed all the way out making the spacer as thin as possible.Conclusion: the majority of the damage to the spacer appears to be the result of the removal process.The body of the spacer and hinge area do not appear to be cracked or fractured.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: 7841178
• Report Number: 1030489-2018-01204
• Device Sequence Number: 1980826
• Product Code: MAX
• UDI-Device Identifier: 00643169430778
• UDI-Public: 00643169430778
• 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,Followup
• Report Date (Section B): 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2026
• Device Catalogue Number: 8880823
• Device Lot Number: 0651416W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/20/2018; 10/10/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/05/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR