MAUDE Adverse Event Report: AESCULAP AG TSPACE PEEK IMPLANT 5 26X11.5X8MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	SJ908P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on going.Should additional relevant information become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a tspace peek implant (5° angle, 26 mm length, 11.5 mm width, 8 mm height) was used during a surgical procedure.According to the complainant, the implant fractured while attempting to place in the disc area.The device was removed from the patient, and the procedure was completed using a replacement device.The procedure was delayed approximately twenty (20) minutes.The patient was noted as having "mild" injuries.The treatment was indicated as having been fine.No further complications were reported as a result of this event.The event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: we made a visual inspection of the broken cage, especially of the fracture surfaces.The cage is cracked in two pieces at the interface- area.The fracture surfaces of the broken off piece also the surfaces of the cage did not show any hints for a material failure like knit lines or blowholes.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 / preventive measures: on the basis of the current information and the investigation results, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.Based on the investigations and results of the 8d report a capa is not necessary.".

• Brand Name: TSPACE PEEK IMPLANT 5 26X11.5X8MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10555956
• Report Number: 9610612-2020-00534
• Device Sequence Number: 14055925
• 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,foreig
• 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: 07/01/2024
• Device Model Number: SJ908P
• Device Catalogue Number: SJ908P
• Device Lot Number: 52531623
• 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