MAUDE Adverse Event Report: STRYKER GMBH G4 LAG SCREW D10,5XL90; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600090S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During clinical study pegasus, deep vein thrombosis was reported.Patient contact orthopaedic pa regarding swelling on 17/oct/2023 and went to ed on (b)(6) 2023 where doppler revealed dvt of lle and baker's cyst.Ct angiogram on (b)(6) 2023.Patient taking oral blood thinner and following up with vascular surgeon.Describe treatment: taking oral anticoagulants, did ct angiogram, seeking opinions on surgical treatment option.Potential interventional vascular intervention.
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.H3 other text : device disposition is unknown.

• Brand Name: G4 LAG SCREW D10,5XL90
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18521793
• Report Number: 0009610622-2024-00038
• Device Sequence Number: 20516339
• Product Code: HSB
• UDI-Device Identifier: 07613327510928
• UDI-Public: 07613327510928
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: 81600090S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/16/2024
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 82 KG