MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	58-1028-1210K
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Fall (1848); Unspecified Musculoskeletal problem (4535)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the reported event, the patient fell approximately a month following implantation of the device and the fixation devices used to supplement the fusion process failed from excessive force.The prolift implant is indicated to function only with supplemental fixation and thus it is reasonable to expect the implant to expel if the fixation is no more.As the patient was only month into the fusing process, it is very likely that fusion was not complete, as an 8-week minimum time is estimated for fusion with life spine's pedicle screw system, varying from patient to patient.Without a full fusion, the entire implant system failed to withstand the excessive loads from the fall and led to the failure reported.
Event or Problem Description
It was reported that the patient fell from a standing position approximately a month out from surgery.L5 inferior screws broke out of the pedicle inferiority and the prolift cage retropulsed posteriorly, lateral to the spinal canal.

• Brand Name: PROLIFT
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 14788271
• Report Number: 3004499989-2022-00007
• Device Sequence Number: 5812945
• Product Code: MAX
• UDI-Device Identifier: 00190837086527
• UDI-Public: (01)00190837086527(17)241122(10)AXX0523-1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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: Other
• Device Expiration Date: 11/22/2022
• Device Model Number: 58-1028-1210K
• Device Catalogue Number: 58-1028-1210K
• Device Lot Number: AX0523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male