MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 4.0MM / L48MM; PLATE, FIXATION, BONE

Model Number	371548
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Inaccurate Information (4051)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	10/12/2021
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 discarded/legal case.
Event or Problem Description
It was reported that the patient broke her left shoulder and had plate put in her arm.She had a reaction to the plate and the plate was removed.Paper in box with plating system had different information than what was documented online.The patient wants more information on the blood test that was supposed to be conducted before the patient was implanted with the stryker plate.The patient alleges that the surgeon never did the blood test.3 months after the plate was implanted the patient experience a severe reaction with immense swelling and pain.Patient said the surgeon told her that the reaction was in her head.Patient states that she was "toxic" due to the nickle that was being emitted from the stainless steel material the plate was made of.Patient alleges that if the surgeon had conducted the required blood work prior to the surgery, this issue could have been mitigated by the use of a titanium plate instead.The patient mentioned she is working with her attorney on a case against the surgeon and the hospital and mentioned that she also felt stryker had some liability in this as well.

• Brand Name: LOCKING SCREW AXSOS 4.0MM / L48MM
• 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: 15833869
• Report Number: 0008031020-2022-00630
• Device Sequence Number: 5391680
• Product Code: HRS
• UDI-Device Identifier: 07613154864386
• UDI-Public: 07613154864386
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 371548
• Device Catalogue Number: 371548
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/21/2022
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG