MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SCR-V MINI SBM 3.3MM 3.5MM 10MM; SCREW VENT IMPLANT

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted to report (b)(4).Additional 510k: k011028|k013227.The device has not been received, as it remains implanted in the patient's mouth, however, an investigation of the reported event will be completed.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient felt the implant was causing physical problems at tooth location 27.The implant was removed.The patient was placed on antibiotics and will return for a follow-up appointment.

Event Description

It was reported that the patient felt the implant was causing physical problems at tooth location 27.The implant was removed.The patient was placed on antibiotics and will return for a follow-up appointment.

Manufacturer Narrative

This report is being submitted to relay additional information.0002023141-2019-00140-2 has also been submitted.The following sections are being reported: b5: it was reported that the patient felt the implant was causing physical problems at tooth location 27.The implant was removed.The patient was placed on antibiotics and will return for a follow-up appointment.D4: expiration date: 30 august 2022 udi: (b)(4), d10: 12 mar 2019, g4: 21 june 2019, g7: follow up 2, h1: malfunction, h2: additional information, device evaluation, h3: yes, h4: 30 aug 2017.The reported device was received for evaluation.The returned product was measured using calipers and was verified to match specifications.The reported condition of the implant causing physical problems at tooth location 27 could not be recreated due to the nature of the event.The complaint is not related to the functional performance of the device.The reported condition could not be confirmed.A device history record (dhr) review was completed for the reported device lot it was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.A complaint history review was performed for the reported device lot for similar cause and no other complaint was identified.A definitive root cause could not be determined for the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trend.

Event Description

It was reported that the patient felt the implant was causing physical problems at tooth location 27.The implant was removed.The patient was placed on antibiotics and will return for a follow-up appointment.

• Brand Name: IMPL SCR-V MINI SBM 3.3MM 3.5MM 10MM
• Type of Device: SCREW VENT IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8489124
• MDR Text Key: 141111333
• Report Number: 0002023141-2019-00142
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K061410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: SVMB10
• Device Lot Number: 63746587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR