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Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Patient weight is unknown.Event day and month unknown.One (1) unknown bone staple: speed /unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is unknown.It was approximately 8 weeks prior to (b)(6) 2017.Explant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that an unknown bme speed compression implant had backed out of the clavicle and was able to be felt through the skin.The implant was originally implanted during an open reduction internal fixation (orif) clavicle approximately 8 weeks ago.The patient felt a bump under the skin and had a follow-up appointment this week.The clavicle is healed; however, it healed a little short.The surgeon felt the patient was non-compliant and that contributed to the implant backing out.At some point, the implant will be removed, but has yet to be scheduled.This report is for 1 unknown bone staple: speed.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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