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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG
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MDT SOFAMOR DANEK PUERTO RICO MFG Back to Search Results
Catalog Number G6623513
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/18/2019
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
Pre-operative diagnosis: fracture - dislocation.Procedure: anterior cervical fixation levels implanted: c5-6.It was reported post-op, the implanted screw loosened.It was found that the angle of the screw on caudal side became shallower and changed.No patient complications were reported.
 
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Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
MDR Report Key8801645
Report Number1030489-2019-00782
Device Sequence Number11436248
Product Code OVE
UDI-Device Identifier20643169338788
UDI-Public20643169338788
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K141599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/18/2019
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 NumberG6623513
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2019
Initial Report FDA Received Date07/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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