Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Date 06/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It is reported during clinic follow up on (b)(6) 2015, an x-ray revealed the screw at left lumbar 4 was broken.During another follow up on (b)(6) 2015 it was noted that the screw on right lumbar 4 was also fractured.The hardware was removed on (b)(6) 2015 and on (b)(6) 2015 the patient underwent an anterior lumbar fusion with instrumentation.Patient symptom prior to discovery was low back pain.The patient's fusion status at the time of removal was non-union.For the original surgery the patient's indications were the following: lumbar 4-5 instability, lumbar 4-5 posterior decompression, interbody fusion, instrumentation.
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Manufacturer Narrative
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Based on the reported complaint and visual evaluation of the returned device, no additional evaluation will be performed on this device as there is no reported failure of this device or visual damage identified.Supplemental report two of two for the same event, reference 3003853072-2015-00013-3.
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Search Alerts/Recalls
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