MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT MEDIUM 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.026S
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The devices were implanted on (b)(6) 2019 by dr.(b)(6).Images were provided of the devices prior to removal.There is no indication of a malfunction of the devices and the devices appear to be in good positioning.The patient is experiencing pain.The source of the pain may be attributed to over distracted facets.The reporter indicates this is evident in the x-ray provided.The implants are 6mm height which is not the smallest offering.The facets are over distracted due to the height of the implants.Thus the devices are contributing to the patient's pain.There were no indicated patient comorbidities or pre-existing conditions.The patient had mobi-c devices implanted in both levels prior to prodisc c implantation.The patient had mobi-c implanted on an unknown date at c4/5 and c5/6.These were replaced with pdc devices on (b)(6) 2019, and then replaced with plate and allograft spacer on (b)(6) 2021.The patient underwent revision and removal of a 2-level prodisc c construct at c4/5 and c5/6 on (b)(6) 2021.The devices were removed due to patient pain which is believed to be from over distracted facets.The prodisc c devices were replaced with acdf using a plate and allograft spacer.Only the explanted pdc levels were fused, no additional levels were treated.Patient diagnosis post incident is unknown.
Additional Manufacturer Narrative
The information and images provided by the reporter indicate that this patient underwent removal/revision to acdf due to pain.The cause of the pain was attributed to over distraction of the facets.Based on the imaging and implant sizing, this is believed to be due to use of implant heights that were too tall.6mm high implants were used when a 5mm height may have placed less distraction on the facets.The patient also had prior surgery and tdr devices implanted at both pdc levels.The patient's condition and device contribution to the pain led to a determination that this was a reportable adverse event.Dhr review did not find any problems in manufacturing.Complaint history found the rate of complaints was improbable and no complaints have been identified indicating over distracted facets.The risks associated with this complaint are identified and the complaint rate is acceptable based on the risk assessment.Devices were retrieved and shipped to exponent for evaluation under (b)(4).The ifu and stg caution against use of the device at more than one level and for patients with more than 1 level of scdd.Additional precautions against use of the devices at levels with prior surgery are indicated.The smallest device height is to be used compared to adjacent healthy discs.The information suggests that the smallest height was not used and the surgeon elected to use the device despite the unknown safety and effectiveness of the device based on patient conditions.The investigation determined that a use error in patient selection and implant sizing led to the over distracted facets.The multi-level use of the devices may also have been a contributing factor.This report is for 1 of 2 devices involved in this event.

• Brand Name: PRODISC C US IMPLANT MEDIUM 6MM
• Common Device Name: PROSTHESIS, 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: 12897260
• Report Number: 3007494564-2021-00108
• Device Sequence Number: 3900451
• Product Code: MJO
• UDI-Device Identifier: 00843193112767
• UDI-Public: 00843193112767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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: 03/31/2022
• Device Model Number: 09.820.026S
• Device Catalogue Number: N/A
• Device Lot Number: H624417
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2018
• 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: 40 YR
• Patient Sex: Unknown