MAUDE Adverse Event Report: AESCULAP AG TSPACE XP IMPLANT 5° 30X11.5X7MM; TSPACE XP IMPLANTS

Model Number SO937P

Device Problem Unintended System Motion (1430)

Patient Problem Laceration(s) (1946)

Event Date 01/10/2023

Event Type  Injury  

Event Description

It was reported to aesculap inc.That a tspace xp implant 5° 30x11.5x7mm ( product # so937p) was implanted during a 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 about 20 minutes.The implant was reported to not be available for evaluation.The adverse event/malfunction is filed under aic reference (b)(4).Associated medwatch reports: 400585235_2916714-2023-00027_mdr; 400588773_2916714-2023-00029_mdr.

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

Investigation complete.

Manufacturer Narrative

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.

• Brand Name: TSPACE XP IMPLANT 5° 30X11.5X7MM
• Type of Device: TSPACE XP IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16340263
• MDR Text Key: 309197905
• Report Number: 2916714-2023-00028
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04046964229053
• UDI-Public: 4046964229053
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023,08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO937P
• Device Catalogue Number: SO937P
• Device Lot Number: 52466420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2023
• Distributor Facility Aware Date: 01/11/2023
• Device Age: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female