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

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/25/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 293342697
• Report Number: 0008031020-2022-00272
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540368584
• UDI-Public: 04546540368584
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 430205
• Device Catalogue Number: 430205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2022
• 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): Other
• Patient Sex: Female