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Adverse Event Report

AESCULAP AG & CO. KG SOCON SCREW, 6MM X 40MM, TITANIUM ALLOY SPONDYLOLISTHESIS SPINAL FIXATION SCREW   back to search results
Catalog Number FG629T
Event Date 01/06/2000
Event Type  Injury   Patient Outcome  Other; Required Intervention
Event Description

Original surgery in 1999; left l5 nerve root with l5-s1 spondylolisthesis and l5-s1 disc protrusion. Patient reported to have been in a motor vehicle accident. During physical therapy on 12/06/1999, pt reported hearing a "pop" and experienced pain in his lower back. Examination of x-rays revealed broken implant. Revision surgery in 2000 - one screw fractured and one clamp loose. The 6mm diameter implants removed and replaced with 7mm diameter implants, and the spinal construct taken up one level (l4-s1). Pt reported to be doing fine post-operatively. This event type is occurring below the frequency and severity that are usual for this device system.

 
Manufacturer Narrative

Device eval results were rec'd from the mfr (aesculap ag & co. Kg) which indicated that the mfg documentation confirmed that the device was in compliance with the specs. The eval pictures showed fine structural lines possibly concluding that the failure was due to fatigue.

 
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Brand NameSOCON SCREW, 6MM X 40MM, TITANIUM ALLOY
Type of DeviceSPONDYLOLISTHESIS SPINAL FIXATION SCREW
Baseline Brand NameSOCON SCREW, 06MM X 40MM
Baseline Generic NameSPONDYLOLISTHESIS SPINAL FIXATION
Baseline Catalogue NumberFG629T
Other Baseline ID Number5068390 (LOT NUMBER)
Baseline Device FamilySOCON IMPLANTS
Baseline Device 510(K) NumberK970285
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/27/1997
Manufacturer (Section F)
AESCULAP AG & CO. KG
p.o. box 40
tuttlingen
GERMANY 78501
Manufacturer (Section D)
AESCULAP AG & CO. KG
p.o. box 40
tuttlingen
GERMANY 78501
Manufacturer Contact
lia jones
1000 gateway blvd
so. san francisco , CA 94080
(650) 624 -5073
Device Event Key250668
MDR Report Key258839
Event Key242615
Report Number2916714-2000-00001
Device Sequence Number1
Product CodeMNH
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial,Followup
Report Date 01/11/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFG629T
Device LOT Number5068390
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/07/2000
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2000
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/27/2000 Patient Sequence Number: 1
#TreatmentTreatment Date
1,FG601T: SOCON CLAMP, TITANIUM ALLOY.,

Database last updated on January 30, 2009

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