MAUDE Adverse Event Report: AESCULAP AG TSPACE XP IMPLANT 5 30X11.5X9MM; IMPLANTS INTERBODY FUSION

Model Number SO939P

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

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 a tspace implant.When the implant was open, it was not contained in the inner clear insert.Per the reporter, there seemed to be some xp "dust" on the backside of the sterile packaging.Another implant was opened without issue.There was no harm to the patient.This incident did not occur in surgery.The malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation results: no product at hand.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause: without the product available for analysis, a definitive root cause cannot be determined.A capa is not necessary.

• Brand Name: TSPACE XP IMPLANT 5 30X11.5X9MM
• Type of Device: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9776925
• MDR Text Key: 181784579
• Report Number: 9610612-2020-00018
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K151056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO939P
• Device Catalogue Number: SO939P
• Device Lot Number: 52340408
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1