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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 INTERLAMINAL
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MDT SOFAMOR DANEK PUERTO RICO MFG ZEPHIR ANTERIOR CERVICAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number 8792113
Medical Device Problem Codes Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Implanted date: only year valid.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 as per a litigation complaint that on an unknown date in 2013, the patient underwent a surgery due to cervical injury caused from an accident in the school.Allegedly, a cervical vertebra was surgically implanted.On an unknown date, post-op, the implant was found broken and loosened.No more information is available now.
 
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Brand Name
ZEPHIR ANTERIOR CERVICAL 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 Key9500931
Report Number1030489-2019-01446
Device Sequence Number2981143
Product Code KWP
UDI-Device Identifier00673978955261
UDI-Public00673978955261
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K994239
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/19/2019
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 Number8792113
Device Lot NumberH12D4294
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/19/2019
Initial Report FDA Received Date12/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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