MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Model Number 7510050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Neuropathy (1983); Pain (1994); Vomiting (2144); Sore Throat (2396); Neck Pain (2433)
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Event Date 12/04/2009 |
Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that on (b)(4) 2009, patient underwent anterior cervical discectomy and fusion (acdf) levels implanted: c5-c6, c6-c7 -extrapharyngeal anterolateral approach where rhbmp-2 was used.Pre-op diagnosis: degenerative disc disease onset (b)(6) 2009- pain, mild to moderate (in recovery room s/p index surgery).Onset (b)(6) 2009- nausea (in recovery room s/p index surgery.Onset (b)(6) 2009- nausea/vomiting (attributed by patient to narcotic pain medication).Onset (b)(6) 2009- sore throat (attributed by patient to endotracheal tube).Onset (b)(6) 2009-pain, minimal (neck).Onset (b)(6) 2009- "tension", left side of neck radiating to left trapezius.
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Event Description
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Adverse event 4: onset (b)(6) 2009 - sore throat (attributed by patient to endotracheal tube).Primary diagnosis: sore throat (post-op day#3; attributed by patient to endotracheal tube) relatedness: surgical procedure associated severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2009.Adverse event 5: onset (b)(6) 2009 - pain, minimal (neck).Primary diagnosis: pain, minimal (neck) (event occurrence: (b)(6) 2009) relatedness: surgical procedure associated severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2010.Adverse event 7: primary diagnosis: "tension", left side of neck radiating to left trapezius (while wearing cervical collar) (event occurrence: (b)(6) 2009) relatedness: not related severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2009.
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Event Description
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It was reported that ae#1 onset (b)(6) 2009.Interscapular pain after acdf surgery.Relatedness: surgical procedure associated.Diagnostic test: no.Surgical treatment: no.Severity: mild.Outcome: resolved, resolution date: (b)(6) 2009.Sae: no.Ae#6 (modified) onset (b)(6) 2009, neck pain after acdf surgery.Diagnostic test: no.Surgical treatment: no.Severity: mild.
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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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