MAUDE Adverse Event Report: SPINE WAVE, INC. LEVA TI PX DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Catalog Number	11-7223
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received for evaluation.The implant displayed significant damage and was received broken.The breakage and much of the damage observed is consistent with the reported removal method.A thorough visual examination was performed.Based on this information, it appears the device was not fully expanded during insertion.The exact cause of this condition could not be definitively determined.A review of the device history record found no issues for the identified production lot.
Event or Problem Description
Approximately 8 months post-operatively, it was noted on radiographic imaging that the implant lost height.No patient complications were reported.A surgical procedure was performed to remove the implant.

• Brand Name: LEVA TI PX DEVICE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton 06484
• MDR Report Key: 7154837
• Report Number: 3004638600-2017-00011
• Device Sequence Number: 13899801
• Product Code: MAX
• UDI-Device Identifier: 10840642106763
• UDI-Public: 10840642106763
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K141980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/06/2019
• Device Catalogue Number: 11-7223
• Device Lot Number: 734N08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/29/2017
• 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: 41 YR