EXOS LONG THUMB SPICA II (LTSII), FOREARM BASED, BLK, XS, L 232-31-1111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-06-26 for EXOS LONG THUMB SPICA II (LTSII), FOREARM BASED, BLK, XS, L 232-31-1111 manufactured by Djo, Llc.

MAUDE Entry Details

• Report Number: 9616086-2019-00027
• MDR Report Key: 8734880
• Report Source: FOREIGN,USER FACILITY
• Date Received: 2019-06-26
• Date of Report: 2019-06-25
• Date of Event: 2018-01-24
• Date Mfgr Received: 2018-01-24
• Device Manufacturer Date: 2017-09-21
• Date Added to Maude: 2019-06-26
• 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. BRIAN BECKER
• Manufacturer Street: 2900 LAKE VISTA DRIVE
• Manufacturer City: LEWISVILLE TX 75067
• Manufacturer Country: US
• Manufacturer Postal: 75067
• Manufacturer G1: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
• Manufacturer Street: CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
• Manufacturer City: TIJUANA, B.C. 22244,
• Manufacturer Country: MX
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EXOS LONG THUMB SPICA II (LTSII), FOREARM BASED, BLK, XS, L
• Generic Name: ORTHOSIS, LIMB BRACE
• Product Code: IQI
• Date Received: 2019-06-26
• Returned To Mfg: 2018-05-14
• Model Number: 232-31-1111
• Lot Number: 170921-AA
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DJO, LLC
• Manufacturer Address: 1430 DECISION STREET VISTA CA 920819663 US 920819663

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-06-26