SYNTHES GMBH 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.019.038S |
Device Problem
Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/14/2022 |
Event Type
Injury
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Event Description
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Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to treat humerus.
The patient did not underwent unreasonable rehabilitation, but cut-out progressed as the patient progressed to 1 to 2 weeks after the initial surgery.
According to surgeon the postoperative reduction was good.
A revision surgery is not planned.
No further information is available.
This report is for one (1) 4.
5mm ti multiloc screw length 38mm-sterile.
This is report 4 of 7 for complaint (b)(4).
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.
(b)(4).
The investigation could not be completed; no conclusion could be drawn, as no product was received.
Based on the information available, it has been determined that no corrective and/or preventative action is proposed.
This complaint will be accounted for and monitored via post market surveillance activities.
If additional information is made available, the investigation will be updated as applicable.
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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Search Alerts/Recalls
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