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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 G6626527
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product code (ove): intervertebral fusion device with integrated fixation, cervical (b)(4).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.
 
Event or Problem Description
Pre-op diagnosis: cervical hernia.Procedure: cervical anterior fusion it was reported that on unknown date, post-op, the implant got deviated in the patient's body.A revision surgery was performed for fixation.
 
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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 Key6662687
Report Number1030489-2017-01617
Device Sequence Number1882058
Product Code OVE
UDI-Device Identifier00643169337435
UDI-Public00643169337435
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K141599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberG6626527
Device Lot NumberH5217677
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2017
Initial Report FDA Received Date06/23/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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