MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965045S
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Customer service was contacted by a patient informing she has been suffering from severe skin rashes and pain after an implant emergency surgery in the upper arm and requests sample of the composition (metals etc) of the implants and screws as well as a sample of the implants so that the lab/dermatologist can determine whether the parts need to be removed or whether there is another solution.
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned.A picture of the patient condition was provided: skin rashes can be observed.However, without further detailed information (such as allergic tests results) it cannot be determined whether the implant is responsible for this reaction.It is worth noting that as requested, the material composition of the implant was forwarded to the reporter.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Customer service was contacted by a patient informing she has been suffering from severe skin rashes and pain after an implant emergency surgery in the upper arm and requests sample of the composition (metals etc) of the implants and screws as well as a sample of the implants so that the lab/dermatologist can determine whether the parts need to be removed or whether there is another solution.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X45 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22950343
• Report Number: 0008031020-2025-01443
• Device Sequence Number: 20897950
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: (01)04546540202505(17)291031(10)K1E1B74
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: Lay User/Patient
• Device Catalogue Number: 18965045S
• Device Lot Number: K1E1B74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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: Other
• Patient Sex: Unknown