MAUDE Adverse Event Report: ZIMMER DENTAL UNK ZIMMER SCREW; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 02/18/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Fax number unknown / not provided.Pma/510(k) number not available.Manufacture date not available.

Event Description

It was reported that the screw fractured inside the implant in tooth location #10.The fractured portion was not able to be removed from the implant and the head of the screw in the overdenture.

Event Description

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

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4) one impl tapered sp 3.7mm 14m m octagon (spb14) was returned for investigation.Visual inspection of the as returned product identified significant wear on the implant threads and the collar.The internal drive feature was confirmed to contain the fractured piece of the reported screw, which was too badly damaged to be removed or identified.Signs of removal are noted on the screw and implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing conditions noted on the per.However, tooth site was 22 (fdi) at the time of event.Implant was placed for approximately 15 years 2 months.X-ray and picture images were not provided.Review of appropriate documentation: documents reviewed: instructions for use for swissplus® and tapered swissplus® implants¿ 9967 rev 2-10/19; warnings + precautions; page 2 instructions for use ¿ prosthetics for zimmer dental implant systems ¿ ifu4894 rev 6 ¿ 08/19.Information identified: contraindications & precautions (pages 3 & 4).Per the applicable ifu, patient factors such as severe bruxism, clenching, and overloading, may cause component fracture.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 the distribution of conforming product within specifications.A complaint history review could not be performed without relevant item and lot information.January post market trending was reviewed and there were no actionable trends or corrective actions for the reported devices and events.Therefore, based on the available information, screw malfunction did occur and the reported event was confirmed.

• Brand Name: UNK ZIMMER SCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11125803
• MDR Text Key: 225566103
• Report Number: 0002023141-2021-00029
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR