Product complaint # = > (b)(4) investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: h6 (patient and device codes) h6 patient code: no code available (3191) used to capture the prolonged surgery and insufficient information.H6 device code: no code available (3191) used to capture the functional: trial does not replicate the implant.
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