Model Number MSB_UNK_BMP2_ACS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Osteolysis (2377)
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Event Type
Injury
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Event Description
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The information was received from health acre provider via a manufacturing representative regarding a patient for alif spinal therap y.It was reported that patient underwent a alif in (b)(6) 2021 and has persistent pain in her lumbar spine with mri findings suggesting to be consistent with possible bmp inflammatory reaction.Patient is experiencing back pain, radiculitis and osteolytic changes.There was no further information reported.
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Manufacturer Narrative
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Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.B2: other : inflammation, osteolysis.H6: 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.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.Adverse event: other: inflammation, osteolysis.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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The information was received from health acre provider via a manufacturing representative regarding a patient for alif spinal therapy.It was reported that patient underwent a alif in (b)(6) 2021 and has persistent pain in her lumbar spine with mri findings suggesting to be consistent with possible bmp inflammatory reaction.Patient is experiencing back pain, radiculitis and osteolytic changes.There was no further information reported.
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Search Alerts/Recalls
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