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

Model Number PDL-L-PT10S

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 02/24/2020

Event Type  Injury  

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 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.

Manufacturer Narrative

Correct manufacturer for synthes to centinel spine, llc.

• Brand Name: PRODISC L US
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester, pa
• MDR Report Key: 9849316
• MDR Text Key: 188001499
• Report Number: 3007494564-2020-00017
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PDL-L-PT10S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR