IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM
Report
- Report Number
- 0002023141-2024-04024
- Event Type
- Injury
- Date Received
- December 14, 2024
- Date of Event
- November 4, 2024
- Report Date
- April 2, 2025
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019560
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K011028/K013227.
ZIMVIE RECEIVED ONE (1) TSVH10, (IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. THE IMPLANT WAS TREPHINED OUT AND WAS IDENTIFIED FRACTURED AT THE COLLAR. ALSO, A FRACTURED SCREW WAS IDENTIFIED STUCK INSIDE THE IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1221081. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1221081 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿FRACTURE IMPLANT¿. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 4, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE PARAFUNCTIONAL HABITS/PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.
THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, B5. DESCRIBE EVENT OR PROBLEM, G3: DATE RECEIVED BY MANUFACTURER, G6: CHECKED "FOLLOW-UP, H2: CHECKED FOLLOW-UP TYPE, H6: ENTERED EVALUATION CODES, H10: ADDED MANUFACTURER NARRATIVE.
IT WAS REPORTED IMPLANT FRACTURED AT BASE, TOOTH 30. NO DELAY DURING THE PROCEDURE. ADDITIONAL APPOINTMENT REQUIRED FOR BONE PLACED IMPLANT IN 4 MONTHS. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED IMPLANT FRACTURED AT BASE, TOOTH 30. NO DELAY DURING THE PROCEDURE. ADDITIONAL APPOINTMENT REQUIRED FOR BONE PLACED IMPLANT IN 4 MONTHS. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. MOST NOTABLY WAS THE PLATFORM FRACTURE ON THE DISTAL ASPECT AND THE ACUTE GINGIVAL INFLAMMATION AS A RESULT. THE SCREW FRACTURE DID NOT HAPPEN DURING THE REMOVAL OF THE IMPLANT. THE IMPLANT WAS TREPHINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2415899 | IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1221081 | 00889024019560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female |