ACE 1365

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-01-23 for ACE 1365 manufactured by Depuy Acromed, Inc..

Event Text Entries

[234165] It was reported to depuy acromed that an ace spring pin was not functioning properly. The product has been returned and is currently being evaluated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1526439-2001-00001
• MDR Report Key: 313727
• Report Source: 08
• Date Received: 2001-01-23
• Date of Report: 2001-01-23
• Date Mfgr Received: 2000-12-22
• Date Added to Maude: 2001-01-29
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 325 PARAMOUNT DR
• Manufacturer City: RAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal: 02767
• Manufacturer Phone: 5088808100
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACE
• Generic Name: SPRING PIN
• Product Code: HAX
• Date Received: 2001-01-23
• Model Number: NA
• Catalog Number: 1365
• Lot Number: 0698W
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 303418
• Manufacturer: DEPUY ACROMED, INC.
• Manufacturer Address: 325 PARAMOUNT DR. RAYNHAM MA 02767 US
• Baseline Brand Name: ACE HALO SYSTEMS
• Baseline Generic Name: HALO, TONGS, PINS
• Baseline Model No: NA
• Baseline Catalog No: 1365
• Baseline ID: NA
• Baseline Device Family: ACE HALO SYSTEMS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K954069
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-01-23