MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE, WITH COLLAR HOLES 8 LENGTH 103MM FOR SCREWS Ø3.5/4.0MM; PLATE, FIXATION, BONE

Model Number	430208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices listed in this report: cat 338612 cortex screw s.T.Ø3.5x12mm, cat 338614 cortex screw s.T.Ø3.5x14mm, cat 338616 cortex screw s.T.Ø3.5x16mm, cat 338620 cortex screw s.T.Ø3.5x20mm, cat 338650 cortex screw s.T.Ø3.5x50mm, cat 390018 washer for screws: ø2.7/3.5/4.0mm.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
The customer reported that: "suspected allergy in a patient.".
Additional Manufacturer Narrative
Correction - please refer to b1, h1-type of reportable event.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The technical drawing of the device was reviewed and it was determined that the chemical composition of the material is defined as din 1.4441.The material composition is described in the table attached to this record.It is important to state that in order to know the exact composition of the plate that was implanted, the lot number of the device is needed.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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
The customer reported that: "suspected allergy in a patient.".

• Brand Name: ONE-THIRD TUBULAR PLATE, WITH COLLAR HOLES 8 LENGTH 103MM FOR SCREWS Ø3.5/4.0MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14344991
• Report Number: 0008031020-2022-00228
• Device Sequence Number: 17463990
• Product Code: HRS
• UDI-Device Identifier: 04546540368614
• UDI-Public: 04546540368614
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 430208
• Device Catalogue Number: 430208
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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