MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that: on an unknown date (b)(6) 2010 the patient presented with pain in his lower back that radiated down his right leg.The patient underwent x-rays and mri.The surgeon recommended surgery.On (b)(6) 2010 the patient underwent axial lumbar interbody fusion procedure at l4-5 and l5-s1 using rhbmp-2.After few weeks status post surgery patient complained that he was still in pain.Patient's pain has recently begun to worsen, his mobility has diminished and is unable to return to his active lifestyle and cannot run or play.Patient is in pain all of the time which is worsening, and has missed work because of it.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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