MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT LARGE-DEEP 5MM; PROTHESIS, INTERVERTEBRAL DISC

Model Number 09.820.055S

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Neck Pain (2433)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

The information provided indicates the patient received a 2-level prodisc c implantation.At 2-years post-op, the patient was scheduled for removal of the c6/7 device.The patient was experiencing radicular pain due to posterior positioning of the device and device shifting.The device was shown to be positioned too far posterior as seen in lateral x-rays.The superior endplate is in an anterior position on the core with the neck in a neutral position.There was also observed degeneration at c4/5 as well as anterior ossification of the prodisc c levels.The removal was performed on (b)(6) 2022.The c6/7 prodisc c device was replaced with a corpectomy cage and plate.There is no indication the c5/6 device was removed.Dhr review did not find any problems in manufacturing which may have contributed to the complaint.Complaint rates were found to be acceptable based on the analysis of the updated dfmea rates.The risk assessment determined the dfmea has identified the risks associated with this compliant.The device was retrieved and shipped to exponent under id# (b)(4).Stage 1 analysis is underway.If device analysis provides information that changes the outcome of this investigation, a follow up submission will be completed.The investigation concluded that the posterior positioning of the device is likely the cause of the complaint and removal.This positioning is attributed to use error while implanting the device.Secondary causes may be attributed to the degenerative changes at the c4/5 level as well as ossification observed on lateral x-rays.This submission is for 1 of 1 devices involved in this event.

Event Description

The patient was implanted with 2x prodisc c us implant large-deep 5mm at c5/6 and c6/7 on (b)(6) 2019.On (b)(6) 2021, the patient was diagnosed to need revision/removal of the prodisc c device.The diagnosis was due to pain in both arms, posterior displacement, and device shifting.The patient did not have any comorbidities.X-ray images provided suggest the pdc device at c6/7 was positioned too far posterior.The images show the superior endplate canted forward in a neutral neck position.Additionally the x-rays show significant degeneration at c4/5 as well as heterotopic ossification anterior to the pdc implants.On (b)(6) 2022 the patient underwent prodisc c removal of the c6/7 implant.The prodisc c was replaced with a corpectomy cage and plate from an unknown manufacturer (not centinel spine, llc.).There is no indication the c5/6 device was removed.

• Brand Name: PRODISC C US IMPLANT LARGE-DEEP 5MM
• Type of Device: PROTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878810
• MDR Report Key: 13587945
• MDR Text Key: 290529671
• Report Number: 3007494564-2022-00004
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193112842
• UDI-Public: 00843193112842
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 09.820.055S
• Device Lot Number: H580351
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR