Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: device history reviewed: no non-conformities on this batch.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional report related to implant loosening.Total for lot number: 1 ((b)(4)).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 9.By product family: 19 (8x depuy cmw 1g, 10x depuy cmw 2g, 1x depuy cmw 3g).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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