MAUDE Adverse Event Report: AESCULAP AG TSPACE PEEK IMPLANT 5 26X11.5X10MM; SPINE SURGERY

Model Number	SJ908P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation on going.Additional information / results will be submitted in a supplemental report.
Event or Problem Description
It was reported that there was an issue with tspace peek implant 5° 26x11.5x8mm according to the complaint description, it was reported that during procedure while putting the disc in the disc area, the product was broken.Additional information received that the disc was replaced by the new one, and the treatment was fine.Patient had mild injuries and there was a 20 mins delay during the surgery.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Visual investigation: we made a visual inspection of the broken cage.The cage shows some cracks, no pieces are broken completely off.The cage is nearly broke in two pieces and shows additionally a crack in the area of the inserter interface.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures: the most likely root causes for an implant fracture during surgery are when the surgeon does not prepare the disc space sufficiently, if a too large implant is chosen, if too much manipulation is done or too hard insertion force applied.Due to the investigation results the root cause is most probably usage related.Based on the investigations and results of the 8d report a capa is not necessary.

• Brand Name: TSPACE PEEK IMPLANT 5 26X11.5X10MM
• Common Device Name: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10556497
• Report Number: 9610612-2020-00536
• Device Sequence Number: 16746723
• Product Code: MAX
• UDI-Device Identifier: 04046963835880
• UDI-Public: 4046963835880
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K071983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: SJ908P
• Device Catalogue Number: SJ908P
• Device Lot Number: 52545406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1