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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. STAXX XD SPINAL VERTEBRAL BODY REPLACEMENT

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SPINE WAVE, INC. STAXX XD SPINAL VERTEBRAL BODY REPLACEMENT Back to Search Results
Catalog Number 11-1323
Device Problems Dislodged; Explanted; Migration or Expulsion of Device
Event Date 10/21/2008
Event Type  Injury  
Manufacturer Narrative

The explanted construct was returned to the manufacturer for evaluation. Visual inspection revealed markings consistent with implantation of the device. Dimensional inspection sampling of the construct did not reveal any abnormalities. Although the surgeon has reported that the patient anatomy and previous surgeries complicated the initial procedure, no conclusion can be drawn from the results of the evaluation.

 
Event Description

It was reported that the patient experienced pain three months post-operatively. The patient underwent revision surgery. During revision surgery, it was reported that the construct was dislodged and the construct had migrated. According to the surgeon, this was a difficult case due to the patient's anatomy and previous surgical procedures. The surgeon reported that the revision surgery was completed successfully.

 
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Brand NameSTAXX XD
Type of DeviceSPINAL VERTEBRAL BODY REPLACEMENT
Manufacturer (Section D)
SPINE WAVE, INC.
shelton CT
Manufacturer Contact
ronald smith
2 enterprise drive
ste. 302
shelton , CT 06484
2039449494
MDR Report Key1241105
Report Number3004638600-2008-00002
Device Sequence Number1
Product CodeMQP
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/22/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number11-1323
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/24/2008
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received10/22/2008
Was Device Evaluated By Manufacturer? Yes
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: 11/21/2008 Patient Sequence Number: 1
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