MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY INFINITY IMPLANT SYSTEM; INTERNAL HEX

Model Number 203711

Device Problem Folding Issue (2654)

Patient Problem Failure of Implant (1924)

Event Date 11/19/2013

Event Type  Injury  

Event Description

Unsuccessful implant placement failure - aka - same day spinner.Mobility.

• Brand Name: INFINITY IMPLANT SYSTEM
• Type of Device: INTERNAL HEX
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; brockton MA
• Manufacturer Contact: 1034 pearl st.; brockton, MA 02301 ; 8004413100
• MDR Report Key: 3642072
• MDR Text Key: 4284038
• Report Number: 1287163-2014-00007
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 203711
• Device Catalogue Number: 203711
• Device Lot Number: 13100041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR