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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ZEPHIR ANTERIOR CERVICAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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MDT SOFAMOR DANEK PUERTO RICO MFG ZEPHIR ANTERIOR CERVICAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 8792813
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/02/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product was not 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
Procedure: anterior cervical discectomy and fusion (acdf).Levels implanted: c6-7.It was reported that post-op, cephalad screw had backed out anteriorly approximately 3mm, past the locking wire of the interbody device was showed in x-ray.No patient complications were reported.
 
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Brand Name
ZEPHIR ANTERIOR CERVICAL SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
MDR Report Key8690716
Report Number1030489-2019-00618
Device Sequence Number19421592
Product Code KWQ
UDI-Device Identifier00721902610653
UDI-Public00721902610653
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K030327
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) 06/12/2019
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 Number8792813
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/17/2019
Initial Report FDA Received Date06/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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