MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CUSTOMIZED MAND. RECON PLATE28, HEMI; IMPLANT

Catalog Number 78-30028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/14/2023

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 that a revision surgery was performed and completed successfully.

Event Description

It was reported that a revision surgery was performed and completed successfully.

Manufacturer Narrative

Corrected data: per stryker's medical expert, the event was not caused or contributed to the device.It was reported that patient had infection.As a result, surgeon removed the fixation, debrided the infected site and closed.Patient was reported to be on antibiotics.H3 other text : not available.

• Brand Name: CUSTOMIZED MAND. RECON PLATE28, HEMI
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS; 6059 king drive; ventura 93003
• Manufacturer Contact: rylee koole ; 6059 king drive; ventura 93003 ; 8056503391
• MDR Report Key: 17740853
• MDR Text Key: 323332084
• Report Number: 0008010177-2023-00057
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07613252599654
• UDI-Public: 07613252599654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 78-30028
• Device Lot Number: 2302281026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 11/27/2023
• 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