GENTEK¿ANGULATED SCREW CHANNEL TIBASE, CERTAIN¿ ENGAGING, 3.4MMD X 1.3MMCH
Report
- Report Number
- 3008932779-2024-00001
- Event Type
- Injury
- Date Received
- September 11, 2024
- Report Date
- January 31, 2025
- Manufacturer
- ZFX GMBH
- Product Code
- NHA
- PMA / PMN Number
- K231915
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER(B)(4). D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED.
ZIMVIE COMPLAINT NUMBER CMP-(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H10: ADDITIONAL NARRATIVE ONE (1) ZFX11ZB-CE34AS13E, (GENTEK ANGULATED SCREW CHANNEL TIBASE, CERTAIN ENGAGING, 3.4MMD X 1.3MMCH) WAS REPORTED. HOWEVER, THE PRODUCT WAS NOT RECEIVED FOR EVALUATION. THE PRODUCT WAS LOST IN TRANSIT. THEREFORE, A VISUAL/PHYSICAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER AND RISK MANAGEMENT FILE (RMF). UPON LOCATING THE DEVICE, THIS COMPLAINT RECORD WILL BE REOPENED AND UPDATED ACCORDINGLY. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE ZFX11ZB-CE34AS13E DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE. DHR REVIEW AND COMPLAINT HISTORY REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. HOWEVER, ZFX QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE 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.
WHEN THE CROWN WAS PLACED, THE SCREW FRACTURED INSIDE THE IMPLANT, WHICH CAUSED THE IMPLANT REMOVAL. PROCEDURE COMPLETED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1475429 | GENTEK¿ANGULATED SCREW CHANNEL TIBASE, CERTAIN¿ ENGAGING, 3.4MMD X 1.3MMCH | DENTAL SCREW | NHA | ZFX GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male |