MAUDE Adverse Event Report: AESCULAP AG TSPACE TITANIUM IMPLANT 5° 26X12X13MM; SPINE SURGERY

Model Number FJ700R

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

This is a similar device report, a similar device of the reported device was sold to us the reported device is not marketed in the us.Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with fj700r - tspace titanium insertion instr.Str.According to the complaint description, the cage loosened during implantation, threaded rod broken.An additional medical intervention was necessary.Surgery was completed successfully.Additional information was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: sj333t - tspace titanium implant 5° 26x12x13mm - 52464105.

Manufacturer Narrative

Investigation results: visual investigation: investigation was carried out visually and microscopically.The instrument arrived in common with a implant sj333t.It was clearly visible, that the thread on the instrument tip is broken off.We made a visual inspection of the instrument and the implant.At the instrument we found the threaded tip at the instrument / implant interface broken off, the broken off part was not enclosed.The magnification of the fracture surface exhibit an 70% forced fracture.The arrest- lines on the fracture surface (red circular- lined area) were a hint,that the threaded tip was pre- damaged before the surgery.In the next step we investigated the implant.Here we found deformations / dents in the area of the implant / instrument interface.This is a clear sign for strong leverage during inserting the implant in the spine.The threaded hole of the implant is in a proper condition, it shows no rest of the broken off instrument tip.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2 (5) x probability of occurrence 1(5) according to din en iso 14971 is still acceptable.Explanation and rationale: the damages on the implant interface are a sure evidence for using/applying a too high force.A material failure or a manufacturing error can be excluded.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably usage related.There is no indication for a material, manufacturing or design related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: TSPACE TITANIUM IMPLANT 5° 26X12X13MM
• Type of Device: SPINE SURGERY
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12010397
• MDR Text Key: 265578302
• Report Number: 9610612-2021-00472
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FJ700R
• Device Lot Number: 52532442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SJ333T - 52464105.
• Patient Outcome(s): Required Intervention; Other