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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
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MDT SOFAMOR DANEK PUERTO RICO MFG DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM Back to Search Results
Catalog Number G6626745
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/26/2018
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 underwent spinal surgery due to some unspecified reasons.Intra-op, cage broke while implanting.No patient complications were reported as a result of this event.
 
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Brand Name
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
MDR Report Key7291656
Report Number1030489-2018-00275
Device Sequence Number894492
Product Code OVE
UDI-Device Identifier00643169337534
UDI-Public00643169337534
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K141599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/23/2018
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 NumberG6626745
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/26/2018
Initial Report FDA Received Date02/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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