MAUDE Adverse Event Report: ZIMMER DENTAL IMPLANT, HA, FULL

Catalog Number TSVTWH10

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

Additional 510k number for the device - k133339.

Event Description

The clinician reports that during a procedure on (b)(6) 2017, the implant (tsvtwh10) went into left max sinus and had to be removed surgically in implant in tooth site #14.The sinus was closed and the implant was removed.No implant was placed during that procedure.

Manufacturer Narrative

One tapered screw vent implant was returned for inspection.Visual inspection revealed moderate wear and bone tissue attachment about the threaded region and vent.The internal drive feature is similarly worn from use.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional complaints against this lot number.Appropriate documentation was reviewed and the following information was identified: instructions for use for tapered screw-vent, advent and trabecular metal implants 4869 rev 7-01/16.Zimmer one-piece implant system 7458a, rev.9/07.Warnings other relative warnings include steroid and anticoagulant treatment which may affect the surgical site, surrounding tissue, or patient¿s healing function.Exposure to long-term use of bisphosphonate drugs especially with chemotherapy may impact implant survival.Careful patient selection including consultation with the patient¿s physician is strongly recommended prior to implant treatment.Excessive mobility, bone loss, or infection may indicate the implant is failing.Any implant which appears to be failing should be treated or removed as soon as possible.If removal is necessary, curette any soft tissue from the implant site and allow site to heal as though it were an atraumatic extraction.Due to the metal conductivity, electrosurgery around the implants and intraoral abutment preparations without irrigation could result in tissue damage, patient injury and implant failure.A root cause for the complaint could not be determined with the information provided as the event cannot be recreated.Complaint is therefore non-verifiable.(b)(4).

• Brand Name: IMPLANT, HA, FULL
• Type of Device: IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• Manufacturer (Section G): BIOMET 3I; 1900 aston avenue; carlsbad CA 92008
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6800077
• MDR Text Key: 82893067
• Report Number: 0001038806-2017-00519
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101880
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

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
• Device Operator: Dentist
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: TSVTWH10
• Device Lot Number: 63261022
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR