OBERDORF SYNTHES PRODUKTIONS GMBH 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/18MM; PLATE, FIXATION, BONE
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Catalog Number 04.501.028.01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Pain (1994); Reaction (2414)
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Event Date 07/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Patient's birth year reported as (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.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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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a patient was treated with a matrixrib plate and screws.Initial procedure was completed successfully.On (b)(6) 2020, the patient returned to the hospital due to fever, pain and redness.The implants need to be removed due to infection.Explantation/part removal will not be performed.No further information provided.This report is for one (1) 2.9mm ti matrixrib lckng screw self-tapping/18mm.This is report 5 of 7 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- product was not returned.Based on the information available, it has been determined that no corrective and 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.Part/lot combination are unknown at synthes gmbh, no dhr review possible.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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