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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CENTINEL SPINE PRODISC C US IMPLANT; PROSTHESIS, INTERVERTEBRAL DISC
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CENTINEL SPINE PRODISC C US IMPLANT; PROSTHESIS, INTERVERTEBRAL DISC Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 11/04/2023
Event Type  Injury  
Event Description
Several attempts were made unsuccessfully to collect more information on this case.All that is known is that a prodisc c removal occurred on (b)(6) 2023 from a female patient that the surgeon had implanted roughly 1 year ago.
 
Manufacturer Narrative
Several attempts were made unsuccessfully to collect more information on this case.All that is known is that a prodisc c removal occurred on (b)(6) 2023 from a female patient that the surgeon had implanted roughly 1 year ago.An mdr is indicated for this complaint.A review of the dhr could not be completed as the part number and lot number were not provided and could not be determined during the investigation.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazards associated with this complaint are identified and mitigated to a level where the benefits outweigh the risks.Device evaluation cannot be completed as the as the implant was not returned following removal.It was confirmed that a removal took place but a reason for the removal was not provided.No other anomalies associated with the complaint were found during the investigation.The reason for removal is unknown.The submission is 1 of 1 devices involved in this event.
 
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Brand Name
PRODISC C US IMPLANT
Type of Device
PROSTHESIS, INTERVERTEBRAL DISC
Manufacturer (Section D)
CENTINEL SPINE
900 airport road
suite 3b
west chester PA 19380
Manufacturer Contact
erin ward
900 airport road
suite 3b
west chester, PA 19380
4848878894
MDR Report Key18273687
MDR Text Key329827727
Report Number3007494564-2023-00071
Device Sequence Number1
Product Code MJO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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