LONG NAIL KIT R1.5, TI, LEFT GAMMA3? ?10X260MM X 125? 3525-0260S 35250260S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-27 for LONG NAIL KIT R1.5, TI, LEFT GAMMA3? ?10X260MM X 125? 3525-0260S 35250260S manufactured by Stryker Trauma Kiel.

MAUDE Entry Details

• Report Number: 0009610622-2020-00126
• MDR Report Key: 9890722
• Report Source: OTHER
• Date Received: 2020-03-27
• Date of Report: 2020-03-27
• Date of Event: 2020-03-02
• Date Mfgr Received: 2020-03-02
• Date Added to Maude: 2020-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. SHARON RIVAS
• Manufacturer Street: 325 CORPORATE DRIVE
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal: 07430
• Manufacturer Phone: 2018315000
• Manufacturer G1: STRYKER TRAUMA KIEL
• Manufacturer Street: PROF. KUENTSCHER-STRASSE 1-5
• Manufacturer City: SCHOENKIRCHEN/KIEL D-24232
• Manufacturer Country: DE
• Manufacturer Postal Code: D-24232
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3? ?10X260MM X 125?
• Generic Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Product Code: HSB
• Date Received: 2020-03-27
• Model Number: 3525-0260S
• Catalog Number: 35250260S
• Lot Number: K0C2D90
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER TRAUMA KIEL
• Manufacturer Address: PROF. KUENTSCHER-STRASSE 1-5 SCHOENKIRCHEN/KIEL D-24232 DE D-24232

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-27