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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VENTURE ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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MDT SOFAMOR DANEK PUERTO RICO MFG VENTURE ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number 9791325
Medical Device Problem Code Failure to Align (2522)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/24/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with cervical spondylosis and underwent cervical internal fixation surgery.During surgery, the screw slipped and could not be fixed.The product came in contact with the patient.There were no patient symptoms or complications as a result of this event.
 
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Brand Name
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
MDR Report Key8263462
Report Number1030489-2019-00074
Device Sequence Number2357125
Product Code KWP
UDI-Device Identifier00885074529745
UDI-Public00885074529745
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K061274
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number9791325
Device Lot NumberH5447178
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/24/2018
Initial Report FDA Received Date01/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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