Model Number SO938P |
Device Problem
Unintended System Motion (1430)
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Patient Problem
Laceration(s) (1946)
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Event Date 01/10/2023 |
Event Type
Injury
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Event Description
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It was reported to aesculap inc.That a tspace xp implant 5° 30x11.5x8mm ( product # so938p) was implanted during a transforaminal lumbar interbody fusion (tlif) procedure on (b)(6) 2023.According to the complainant, upon insertion of the trial implant using the articulating inserter; the trial defaulted to 90 degrees prior to entering the disc space, and bumped/tore the dura.Further information received stated that the torn dura was sutured closed.It was reported that the surgery was delayed approximately twenty (20) minutes.The implant was reported to not be available for evaluation.The adverse event/malfunction is filed under aic reference (b)(4).Associated reports: 400585236_2916714-2023-00028_mdr, 400588773_2916714-2023-00029_mdr.
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Manufacturer Narrative
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Investigation on-going.Should relevant additional information / investigation results become available, a supplemental report will be submitted.
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Event Description
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Investigation complete.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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