CORIFIX SCREW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-19 for CORIFIX SCREW manufactured by Corin Medical Ltd.

MAUDE Entry Details

• Report Number: MW5089912
• MDR Report Key: 9097826
• Date Received: 2019-09-19
• Date of Report: 2019-09-17
• Date of Event: 2019-05-10
• Date Added to Maude: 2019-09-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: CORIFIX SCREW
• Generic Name: SCREW, FIXATION, BONE
• Product Code: HWC
• Date Received: 2019-09-19
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CORIN MEDICAL LTD

Device Sequence Number: 2

• Brand Name: SMITH & NEPHEW ENDOBUTTON
• Generic Name: WASHER, BOLT, NUT
• Product Code: HTN
• Date Received: 2019-09-19
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2019-09-19