CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES 400-897 298.801.01S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-03 for CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES 400-897 298.801.01S manufactured by Pioneer Surgical (d.b.a. Rti Surgical).

MAUDE Entry Details

• Report Number: 1833824-2020-00004
• MDR Report Key: 9662207
• Report Source: DISTRIBUTOR
• Date Received: 2020-02-03
• Date of Report: 2020-02-03
• Date of Event: 2019-04-10
• Date Mfgr Received: 2020-01-09
• Device Manufacturer Date: 2018-03-02
• Date Added to Maude: 2020-02-03
• 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. DANIEL NELSON
• Manufacturer Street: 375 RIVER PARK CIRCLE
• Manufacturer City: MARQUETTE MI 49855
• Manufacturer Country: US
• Manufacturer Postal: 49855
• Manufacturer Phone: 9062264489
• Manufacturer G1: PIONEER SURGICAL (D.B.A. RTI SURGICAL)
• Manufacturer Street: 375 RIVER PARK CIRCLE
• Manufacturer City: MARQUETTE MI 49855
• Manufacturer Country: US
• Manufacturer Postal Code: 49855
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES
• Generic Name: CERCLAGE FIXATION CABLE
• Product Code: JDQ
• Date Received: 2020-02-03
• Model Number: 400-897
• Catalog Number: 298.801.01S
• Lot Number: P308467
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PIONEER SURGICAL (D.B.A. RTI SURGICAL)
• Manufacturer Address: 375 RIVER PARK CIRCLE MARQUETTE MI 49855 US 49855

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-03