MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE, WITH COLLAR HOLES 5 LENGTH 64MM FOR SCREWS Ø3.5/4.0MM; PLATE, FIXATION, BONE

Model Number	430205
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device remains implanted in patient.
Event or Problem Description
The patient reported the following: "she would like to know what the material is made of as she suspects a metal allergy.She reportedly had a previous allergy episode with subcutaneous metal electrodes that were put on her back a few years ago.".

• Brand Name: ONE-THIRD TUBULAR PLATE, WITH COLLAR HOLES 5 LENGTH 64MM 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: 14598715
• Report Number: 0008031020-2022-00272
• Device Sequence Number: 19338086
• Product Code: HRS
• UDI-Device Identifier: 04546540368584
• UDI-Public: 04546540368584
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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 Model Number: 430205
• Device Catalogue Number: 430205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/03/2022
• 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: Female