MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Date of event unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Catalog and lot number unknown / not provided.Pma/510(k) number not available.

Event Description

It was reported the patient came with the crown in his hand.The screw fractured inside the implant and doctor proceed to remove the implant.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).One unknown legacy zimmer screw was reported but not returned.There were no allegations against the implant; per complaint description, the implant was removed because the screw fractured.Visual evaluation of the as returned implant identified a hole on the side and damaged threads and platform possibly during removal.Functional testing could not be performed due to the nature of the devices and event.No pre-existing conditions were noted.The reported devices had been placed on tooth # 36 (fdi) for an unknown period of time.X-ray or picture evaluation: picture or x-ray images were not provided.Review of appropriate documentation: documents reviewed: instructions for use ¿ prosthetics for zimmer dental implant systems ¿ ifu4894 rev 6 ¿ 08/19.Instructions for use ¿ swissplus and tapered swissplus implants ¿ ifu9667 rev 2 ¿ 10/19.Information identified: contraindications & warning.Per the applicable ifu, improper technique can cause product failure.Additionally, patient factors such as overloading, bruxism and clenching may result in component fracture and loosening.Dhr review could not be performed for the screw as the lot number was unknown.Complaint history review could not be performed for the screw as the item/lot number was unknown.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Based on the available information the screw malfunction and the reported event (screw fracture) could not be verified as the screw was not returned.

Event Description

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

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11054145
• MDR Text Key: 223067039
• Report Number: 0002023141-2020-02366
• Device Sequence Number: 1
• Product Code: DZA
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR