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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MSD DEGGENDORF MFG CORNERSTONE-SR CAGE SYSTEM

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MSD DEGGENDORF MFG CORNERSTONE-SR CAGE SYSTEM Back to Search Results
Model Number 6272416
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 02/11/2012
Event Type  Death  
Event Description

It was reported that the patient was found dead after implant surgery. Patient's family member called to notify company. No further details provided.

 
Manufacturer Narrative

Death. No further information is provided. (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.

 
Manufacturer Narrative

This device is not approved for sale in the united states, however, a like device, product code mqp, 510k # k041197, has been approved for sale in the united states. Manufacturing date 09/2011. Expiration date 09/2019.

 
Event Description

It was reported that the patient underwent surgery for anterior fusion with anterior cervical plate and peek interbody device to treat cervical disc herniation and spinal stenosis. The patient died the day following surgery due to laryngeal edema. There were no complications during the surgical procedure.

 
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Brand NameCORNERSTONE-SR CAGE SYSTEM
Manufacturer (Section D)
MSD DEGGENDORF MFG
wertstrasse 17
deggendorf 9446 9
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key2460664
MDR Text Key2440443
Report Number1030489-2012-00172
Device Sequence Number1
Product Code ODP
Combination Product (Y/N)N
PMA/PMN NumberNA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/11/2019
Device MODEL Number6272416
Device Catalogue Number6272416
Device LOT NumberUK68
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/22/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/12/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/17/2012 Patient Sequence Number: 1
Treatment
CATALOG # 6272416, LOT# UT48
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