SILEX SACROILIAC JOINT FUSION SYSTEM X079-0053

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 2019-08-13 for SILEX SACROILIAC JOINT FUSION SYSTEM X079-0053 manufactured by X-spine Systems, Inc..

MAUDE Entry Details

• Report Number: 3005031160-2019-00039
• MDR Report Key: 8891062
• Report Source: DISTRIBUTOR
• Date Received: 2019-08-13
• Date of Report: 2019-09-13
• Date of Event: 2019-06-24
• Date Mfgr Received: 2019-08-13
• Device Manufacturer Date: 2014-10-02
• Date Added to Maude: 2019-08-13
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. CASEY MING
• Manufacturer Street: 664 CRUISER LANE
• Manufacturer City: BELGRADE MT 59714
• Manufacturer Country: US
• Manufacturer Postal: 59714
• Manufacturer Phone: 4063880480
• Manufacturer G1: X-SPINE SYSTEMS, INC.
• Manufacturer Street: 664 CRUISER LANE
• Manufacturer City: BELGRADE MT 59714
• Manufacturer Country: US
• Manufacturer Postal Code: 59714
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Generic Name: SACROILIAC JOINT FIXATION / SACROILIAC JOINT FUSION
• Product Code: HTF
• Date Received: 2019-08-13
• Returned To Mfg: 2019-08-15
• Model Number: X079-0053
• Lot Number: XS145628A
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: X-SPINE SYSTEMS, INC.
• Manufacturer Address: 664 CRUISER LANE BELGRADE MT 59714 US 59714

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-13