MAUDE Adverse Event Report: ANATOMAGE INC. ANATOMAGE GUIDE; SURGICAL GUIDE

Device Problems Product Quality Problem (1506); Material Torqued (2980)

Patient Problem No Code Available (3191)

Event Date 10/16/2012

Event Type  Injury  

Event Description

Doctor used guide during surgery and claimed trajectory is too lingual.Doctor also said there may not have been enough acrylic retention because master sleeve moved when he tried to drill.Doctor performed a bone graft in that area and waited 4 months to heal.Implant was placed freehanded after healing.

Manufacturer Narrative

Conclusions: over torquing by user during surgery likely contributed to the sleeve failure that altered the trajectory.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; san jose CA
• Manufacturer Contact: shirley lee ; 111 n market st ste 500; san jose, CA 95113 ; 4088851474
• MDR Report Key: 4199288
• MDR Text Key: 5041383
• Report Number: 3008272529-2014-00015
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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): Other
• Patient Age: 20 YR