MAUDE Adverse Event Report: SPINAL ELEMENTS OMEGALIF; LUMBAR INTERBODY FUSION DEVICE WITH BONE GRAFT

Model Number	72-00-092810-00
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Nervous System Injury (2689)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the review of device history record, it was concluded that the product was inspected and accepted for use and met all specified parameters with no associated nonconformances.No information about how or if the device caused or contributed to event.
Event or Problem Description
After receiving olif surgery patient reportedly had continued leg pain.It is unknown if the symptoms were recurring or new.It is unknown it the device caused or contributed to the event.Original surgery date was not giving and duration of implantation is unknown.Revision surgery occur on (b)(6) 2018 and the implant was removed and discarded.No image or further information was provided.

• Brand Name: OMEGALIF
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): SPINAL ELEMENTS; 1755 west oak parkway; marietta GA 30062
• MDR Report Key: 7546811
• Report Number: 1067095-2018-00001
• Device Sequence Number: 18883124
• Product Code: MAX
• UDI-Device Identifier: 00840916124618
• UDI-Public: 00840916124618
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K150395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/02/2021
• Device Model Number: 72-00-092810-00
• Device Lot Number: 139856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/25/2018
• 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