MAUDE Adverse Event Report: ZIMMER DENTAL; ABUTMENT SCREW

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned to manufacturer fro evaluation.

Event Description

It was reported that an unknown abutment screw loosened.The screw was utilized with a zimmer implant.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: instructions for use for zimmer dental implant systems¿ 4894i rev 3-07/09.Seating of prosthetic components: internal hex or octagon components - to properly seat these prosthetic components, place the abutment retaining screw through the abutment and place the assembly into the internal bevel at the coronal portion of the implant.Rotate it until the abutment drops into place.The male hex or octagon should seat fully in the female hex or octagon of the implant once the torque wrench has been used to tighten the abutment to 30ncm.The x-ray that was provided was evaluated.However, the x-ray can not confirm nor un-confirm the loosening event.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A probable cause cannot be determined.

• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• Manufacturer (Section G): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 7143816
• MDR Text Key: 95949988
• Report Number: 0001038806-2017-00935
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1