MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L US; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-SP11S
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the reporter confirmed the initial assessment that the patient required medical intervention to preclude serious injury.The expulsion of the pe inlay may have been causing or contributing to the patient's pain.It was reported the patient had osteopenia; however, there was no indication if this caused or contributed to the migration/expulsion of the prodisc l inlay.The risk assessment identified 2 risks associated with inlay expulsion.There was no indication of new or unknown risks based on the information provided.Review of complaints determined the complaint rate is within allowable limits established in the dfmea.There are no capas associated with this complaint.Review of the pictures and x-rays provided confirmed inlay expulsion.The investigation could not determine a cause for this adverse event.The device was successfully retrieved and assigned pdl-rd-002 by the third party laboratory.If pertinent information becomes available from the retrieval testing, this report may be updated as appropriate.
Event or Problem Description
Patient was reported to have low back pain which was caused or contributed to by the patient's prodisc l us implant.Imaging of the prodisc l device found the prodisc l pe inlay had expelled from the inferior endplate.Surgical intervention to remove the prodisc l implant was performed on (b)(6) 2020.The patient was converted to a fusion via unknown device from l4 through s1.The prodisc l device was implanted at l5-s1.
Additional Manufacturer Narrative
Correct manufacturer for synthes to centinel spine, llc.

• Brand Name: PRODISC L US
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester, pa
• MDR Report Key: 9849292
• Report Number: 3007494564-2020-00015
• Device Sequence Number: 2610992
• Product Code: MJO
• UDI-Device Identifier: 00843193111746
• UDI-Public: 00843193111746
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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 Model Number: PDL-L-SP11S
• Device Lot Number: 6143417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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: 46 YR