Model Number 615.05.01S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hearing Impairment (1881); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).A device history record (dhr) review was conducted: manufacturing location: (b)(4), inspected and released by: (b)(4), release to warehouse date: 15-mar-2017, expiration date: 28-sep-2018, part number: 615.05.01s, cranios reinforced fast set putty 5cc ¿ sterile, lot number: dse0579 (sterile), lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 09-mar-2017 was reviewed and determined to be conforming.Sterility parameters documented on certificate were reviewed and it is unknown whether exceeding specified maximum may have contributed to the reported complaint condition.This lot met all visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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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It was reported that on an unknown date, the patient underwent a microvascular decompression procedure.Patient was implanted with putty cement norian 5cc.Postoperatively, when the surgeon went to cut it, the patient's hearing decreased to 1m second delay on the baers.Therefore, he cut only part of the nervus intermedius.The surgeon decided not to pursue it any further as the patient has no hearing on the contralateral ear and the postoperative complication was resolved.Patient outcome is unknown.No further information is available.This report is for one (1) cranios reinforced fast set putty 5cc-sterile.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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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