MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L SUPERIOR ENDPLATE LARGE 6 DEGREE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-SP06S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information provided by the reporter indicates the prodisc l inferior endplate migrated anteriorly.Images of the patient indicated the patient suffered a pedicle fracture when they felt the described "pop" sensation.The surgeon indicated they did have any information indicating how the fracture or migration occurred.It is not known if the migration may have caused or contributed to the pedicle fracture.It is not known if the fracture may have caused or contributed to the device migration.Review of device history records did not indicate any issues in manufacturing that would have caused or contributed to this event.The risks associated with the reported event are identified within the risk assessment for this device.There has been no indication in a trend of complaints to suggest corrective action is necessary.The device was successfully retrieved, and as of this report is under evaluation by a third party testing laboratory.
Event or Problem Description
Patient underwent revision surgery to remove a prodisc l construct from the l5-s1 disc space.The patient experienced a "pop" sensation due to unknown circumstances post operatively.The patient was experiencing pain when lying down.The surgeon discovered via x-ray that the patient suffered a pedicle fracture, and the prodisc l inferior endplate had migrated anteriorly.The surgeon determined medical intervention was required to remove the prodisc l construct and replace it with an alif using midline ii-ti cage and midline abo screws.

• Brand Name: PRODISC L SUPERIOR ENDPLATE LARGE 6 DEGREE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 9638546
• Report Number: 3007494564-2020-00001
• Device Sequence Number: 2913063
• Product Code: MJO
• UDI-Device Identifier: 00843193111739
• UDI-Public: 00843193111739
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: PDL-L-SP06S
• Device Lot Number: H599490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/28/2020
• 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: 59 YR