DISTRACTION DRILL GUIDE F/FF901&FF903 FF907R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for DISTRACTION DRILL GUIDE F/FF901&FF903 FF907R manufactured by Aesculap Ag & Co. Kg.

Event Text Entries

[24122992] Eval: eval on-going.
Patient Sequence No: 1, Text Type: N, H10

[24122993] Country of complaint: (b)(6). Drill guide broke during use. Operation delay greater than 15 minutes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3005673311-2015-00095
• MDR Report Key: 5011585
• Date Received: 2015-08-12
• Date of Report: 2017-10-16
• Date of Event: 2015-06-30
• Date Mfgr Received: 2015-07-01
• Date Added to Maude: 2015-08-18
• 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: MS. NICOLE BROYLES
• Manufacturer Street: 615 LAMBERT POINTE DRIVE
• Manufacturer City: HAZELWOOD MO 63042
• Manufacturer Country: US
• Manufacturer Postal: 63042
• Manufacturer Phone: 3145515988
• Manufacturer G1: AESCULAP AG
• Manufacturer Street: PO BOX 40
• Manufacturer City: TUTTLINGEN, 78501
• Manufacturer Country: GM
• Manufacturer Postal Code: 78501
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: DISTRACTION DRILL GUIDE F/FF901&FF903
• Generic Name: DRILL GUIDE
• Product Code: DZJ
• Date Received: 2015-08-12
• Model Number: FF907R
• Catalog Number: FF907R
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AESCULAP AG & CO. KG
• Manufacturer Address: TUTTLINGEN 78532 GM 78532

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-08-12