MAUDE Adverse Event Report: ZIMMER DENTAL; ABUTMENT SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

Device brand is unknown.Product code: is.The item and lot number is not known.The device was not returned for evaluation, remained in use.Pma (510k) is unknown.Device manufacturer date is unknown.Device not returned to the manufacturer.

Event Description

The doctor reported that the patient presented with loose restoration.Upon evaluation it was determine that the unknown abutment screw had loosened at tooth site # 31.The screw was retightened and the patient was released.

Manufacturer Narrative

The unknown zimmer screw was not returned.As a result, visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.Functional testing to recreate the reported event could not be performed since the product was not returned.The screw was located at dental position #31 and was implanted for approximately 8 months.No other pre-existing conditions or device information were noted on the per or in the complaint form.No pictures or x-ray images were provided for the reported event.Dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure that the distribution of non-conforming product is within specifications.A complaint history review could not be performed without relevant item and lot information.Therefore, based on the available information, device malfunction and the reported event could not be verified since the product was not returned and pictorial evidence of the malfunction was not provided by the customer.A definitive cause could not be identified.

Event Description

No further event information available at the time of this report.

• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8714856
• MDR Text Key: 148804718
• Report Number: 0002023141-2019-00304
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1