DYNESYS, HA PEDICLE SCREW + SET SCREW, 6.0X40 N/A 01.03746.040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-11 for DYNESYS, HA PEDICLE SCREW + SET SCREW, 6.0X40 N/A 01.03746.040 manufactured by Zimmer Gmbh.

MAUDE Entry Details

• Report Number: 0009613350-2019-00672
• MDR Report Key: 9304446
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-11-11
• Date of Report: 2020-03-30
• Date of Event: 2019-10-29
• Date Mfgr Received: 2020-03-29
• Device Manufacturer Date: 2018-08-06
• Date Added to Maude: 2019-11-11
• 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. CHRISTINA ARNT
• Manufacturer Street: 56 E. BELL DR.
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal: 46582
• Manufacturer Phone: 5745273773
• Manufacturer G1: ZIMMER GMBH
• Manufacturer Street: SULZER ALLEE 8 SULZER INDUSTRIE PARK
• Manufacturer City: WINTERTHUR 8404
• Manufacturer Country: SZ
• Manufacturer Postal Code: 8404
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DYNESYS, HA PEDICLE SCREW + SET SCREW, 6.0X40
• Generic Name: N/A
• Product Code: MNI
• Date Received: 2019-11-11
• Model Number: N/A
• Catalog Number: 01.03746.040
• Lot Number: 2943463
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER GMBH
• Manufacturer Address: SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-11-11