MAUDE Adverse Event Report: ACE SURGICAL SUPPLY CO TRICAM; DENTAL IMPLANT

Model Number	303516
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event has been determined to be an unsuccessful implant placement failure.This implant loss suggests that the source of the problem was likely to stem from procedural errors.Correct use and procedural instructions are described in this product's instructions for use.
Event or Problem Description
It was reported primary stability and osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.Time of loss in relation to the implant was before restoration.Bleeding was also reported.Bone quality at the time of implant failure was type ii.Implant never fused to the bone.It pulled out when trying to remove the screw.

• Brand Name: TRICAM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY CO; 1034 pearl street; brockton MA 02301
• MDR Report Key: 5427308
• Report Number: 1287163-2016-00189
• Device Sequence Number: 619682
• Product Code: DZE
• UDI-Device Identifier: 00614950005208
• UDI-Public: 00614950005208
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Model Number: 303516
• Device Catalogue Number: 303516
• Device Lot Number: 14050014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2016
• Initial Report FDA Received Date: 02/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR