MAUDE Adverse Event Report: AESCULAP AG TSPACE PEEK/XP/3D TRIAL 5° 30X11.5X8MM; IMPLANTS INTERBODY FUSION

Model Number	SN353R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with so938p - tspace xp implant 5° 30x11.5x8mm.According to the complaint description, the articulating trial inserter was being used and the trial defaulted to 90 degrees prior toentering disc space and tore the dura.This occurred during a transforaminal interbody lumbar fusion (tlif) procedure.The torn dura was sutured and closed.There was a surgical delay of approximately 20 minutes.The implant was then successfully inserted.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: ((b)(4)- so938p); 9610612-2023-00038 ((b)(4) - so937p); 9610612-2023-00036 ((b)(4) - sn305r).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
Update: product code changed to sn353r and item name changed to tspace peek/xp/3d trial 5° 30x11.5x8mm.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2023-00038 ((b)(4)), 9610612-2023-00036 ((b)(4)).
Additional Manufacturer Narrative
Additional information/correction - b5, d1, d2, d4, h5, h8.
Event or Problem Description
Associated medwatch-reports: 9610612-2023-00037 (400585235 - sn353r), 9610612-2023-00038 (400585236 - sn353r), 9610612-2023-00036 (400588773 - sn305r).
Additional Manufacturer Narrative
Investigation results: no investigation method could be applied, because product was not provided for investigation.Device history review: without a provided lot number, the device quality and manufacturing records could not be reviewed.Explanation and rationale: due to the insufficient information, the fact that none of the products complained about is available for inspection / analysis and the fact that the problem described is caused by defective or damaged trial implants as well as a worn insertion instrument or incorrect handling both when coupling the trial implant and when insertion itself can be caused, a valid statistical evaluation cannot be carried out.Thus, neither of the two risk analyzes (trial implant / instrument) is applicable.Conclusion and preventive measures: based upon the investigation results, a clear root cause could not be determined.If the product is returned in the future, an investigation will again be performed at that time.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Based upon the investigation results, a capa is not necessary.

• Brand Name: TSPACE PEEK/XP/3D TRIAL 5° 30X11.5X8MM
• Common Device Name: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16440276
• Report Number: 9610612-2023-00037
• Device Sequence Number: 6138877
• Product Code: HWT
• UDI-Device Identifier: 04046964479267
• UDI-Public: 4046964479267
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: SN353R
• Device Catalogue Number: SN353R
• Device Lot Number: 52340409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 08/03/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/22/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown