MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. SPS Ø3.5X28MM; SCREW, FIXATION, BONE

Model Number 338628

Device Problems Device Appears to Trigger Rejection (1524); Inaccurate Information (4051)

Patient Problems Implant Pain (4561); Swelling/ Edema (4577)

Event Date 10/12/2021

Event Type  Injury  

Event 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.

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.

• Brand Name: CORTEX SCREW S.T. SPS Ø3.5X28MM
• Type of Device: SCREW, 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: 15833983
• MDR Text Key: 304009737
• Report Number: 0008031020-2022-00632
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327080674
• UDI-Public: 07613327080674
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 338628
• Device Catalogue Number: 338628
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2022
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG