MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG NASAL SHELL - REGULAR - 37MM X 19MM X 18MM; IMPLANT

Model Number 9553

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported that after the procedure, the patient experienced pain and discomfort,.A rhinoplasty, chin/cheek implant removal, and grafting revision surgery was performed.

• Brand Name: NASAL SHELL - REGULAR - 37MM X 19MM X 18MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 15175688
• MDR Text Key: 297349969
• Report Number: 0008010177-2022-00027
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: 07613252086260
• UDI-Public: 07613252086260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: A1605044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention