MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLT/QUIKFLAP 3X2 SD AXS; IMPLANT

Catalog Number	12-01542S
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the surgeon will perform a revision surgery to remove the devices due to patient experiencing an allergic reaction.
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Additional Manufacturer Narrative
Update; h6.Corrected data: d9, h3.The reported allergic reaction could not be confirmed due to a lack of additional information.Contact with the stryker sales representative revealed that the implant removal is scheduled for fall 2024.Since the launch of the neuro iii system in 2011, only one other unconfirmed allergy complaint has been reported, with an uncertain root cause.Statistical analysis shows no indication of a design, material, or manufacturing issue.Therefore, no corrective actions are necessary at this time.This complaint will be monitored as part of the ongoing trend analysis, and the record will be revisited if new information becomes available.
Event or Problem Description
It was reported the surgeon will perform a revision surgery to remove the devices due to patient experiencing an allergic reaction.

• Brand Name: PLT/QUIKFLAP 3X2 SD AXS
• Common Device Name: 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 ; 7614888208
• MDR Report Key: 19554370
• Report Number: 0008010177-2024-00050
• Device Sequence Number: 6711091
• Product Code: HBW
• UDI-Device Identifier: 07613327282344
• UDI-Public: 07613327282344
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K171152
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 12-01542S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown