MAUDE Adverse Event Report: STRYKER GMBH TWIST-OFF SCREW FIXOS Ø2.0MM / L12MM; SCREW, FIXATION, BONE

Catalog Number	WS12
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that patient implanted on (b)(6) 2023 with agk09070m is getting worse.It was reported that the patient is allergic to nickel.
Event or Problem Description
It was reported that patient implanted on (b)(6) 2023 with agk09070m is getting worse.It was reported that the patient is allergic to nickel.

• Brand Name: TWIST-OFF SCREW FIXOS Ø2.0MM / L12MM
• Common Device Name: 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: 20074971
• Report Number: 0008031020-2024-00338
• Device Sequence Number: 19601817
• Product Code: HWC
• UDI-Device Identifier: 07613154604555
• UDI-Public: 07613154604555
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K070039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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 Catalogue Number: WS12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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