PRODISC C US IMPLANT UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-13 for PRODISC C US IMPLANT UNKNOWN manufactured by Centinel Spine, Llc..

Event Text Entries

[187999743] A pdc removal case was reportedly scheduled for (b)(6) 2020. Instruments and a retrieval kit were provided to support the case. There was no initial indication of a device problem, patient complications, or other reason for the pdc removal. The case was completed on schedule. No further information is available for this case. Device history review and device evaluation could not be performed. The dfmea for this device was reviewed with no indication of new or unknown risks. Identified risks have been indicated to be mitigated as far as reasonably practicable and/or the benefits outweigh the risk. The device could not be retrieved for unknown reasons from the case despite a kit being provided. If additional information becomes available at a later date this complaint may be updated.
Patient Sequence No: 1, Text Type: N, H10


[187999744] A notification was received through a distributor that a prodisc c implant removal was scheduled for (b)(6) 2020. The reason for the removal has been requested but not provided by the surgeon. It is not known if the patient was experiencing complications in relation to the device. The case was completed on (b)(6) 2020; however, no further information is known about the case or patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007494564-2020-00008
MDR Report Key9707120
Report SourceDISTRIBUTOR
Date Received2020-02-13
Date of Report2020-02-12
Date of Event2020-01-22
Date Mfgr Received2020-01-15
Date Added to Maude2020-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JASON SMITH
Manufacturer Street900 AIRPORT RD, SUITE 3B
Manufacturer CityWEST CHESTER, PA
Manufacturer CountryUS
Manufacturer Phone8878839
Manufacturer G1SYNTHES BRANDYWINE
Manufacturer Street1303 GOSHEN PARKWAY
Manufacturer CityWEST CHESTER, PA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRODISC C US IMPLANT
Generic NamePROSTHESIS, INTERVERTEBRAL DISC
Product CodeMJO
Date Received2020-02-13
Model NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCENTINEL SPINE, LLC.
Manufacturer Address900 AIRPORT RD, SUITE 3B WEST CHESTER, PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-13

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