It was reported to aesculap inc., via the annual activl enhanced safety surveillance study (ess) covering a reporting period from (b)(6) 2023 to (b)(6) 2023, that an unknown activ l device was implanted on an unspecified date at the l4-l5, l5-s1 level.According to the complainant the patient experienced a sensory neurological event at the l4-l5 and l5-s1 level on an unspecified date.The adverse event is filed under aic reference (b)(4), (b)(4).2916714-2024-00052, 2916714-2024-00053.
|
Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
|