IMP,TSV,4.1MM,SBM,11.5
Report
- Report Number
- 0002023141-2023-03030
- Event Type
- Malfunction
- Date Received
- October 24, 2023
- Date of Event
- October 9, 2023
- Report Date
- April 24, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019232
- PMA / PMN Number
- K072589
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: REPORTER EMAIL ADDRESS UNKNOWN / NOT PROVIDED.
ZIMMER BIOMET COMPLAINT NUMBER CMP-(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D3: MANUFACTURER EMAIL ADDRESS D4: ADDITIONAL DEVICE INFORMATION UPDATED D9: DEVICE AVAILABILITY G1: CONTACT OFFICE (AND MANUFACTURING SITE FOR DEVICES) CONTACT NAME AND EMAIL G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H4: DEVICE MANUFACTURER DATE UPDATED H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ZIMVIE DID NOT RECEIVE ONE (1) TSV4B11, (IMP,TSV,4.1MM,SBM,11.5) FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1260102. 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 1260102 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: INCORRECT COMPONENT QUANTITY. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS IMPROPER HANDLING OF DEVICES/PACKAGING OUTSIDE OF ZIMVIE CONTROL. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT/COOB WAS NON-VERIFIABLE SINCE THE CONDITION OF THE PRODUCT/PACKAGING WHEN RECEIVED BY THE CUSTOMER WAS UNKNOWN / NON-VERIFIABLE. 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.
ZIMMER BIOMET COMPLAINT NUMBER CMP-(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D3: MANUFACTURER EMAIL ADDRESS D9: DEVICE AVAILABILITY G1: CONTACT OFFICE (AND MANUFACTURING SITE FOR DEVICES) CONTACT NAME AND EMAIL G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ZIMVIE DID NOT RECEIVE ONE (1) TSV4B11, (IMP,TSV,4.1MM,SBM,11.5) FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1260102. 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 1260102 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: INCORRECT COMPONENT QUANTITY. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS IMPROPER HANDLING OF DEVICES/PACKAGING OUTSIDE OF ZIMVIE CONTROL. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT/COOB WAS NON-VERIFIABLE SINCE THE CONDITION OF THE PRODUCT/PACKAGING WHEN RECEIVED BY THE CUSTOMER WAS UNKNOWN / NON-VERIFIABLE. 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.
IT WAS REPORTED THAT DURING IMPLANT SURGERY WHEN OPENING THE BLISTER, THE DOCTOR NOTICED THE IMPLANT WAS MISSING. PROCEDURE COMPLETED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754107 | IMP,TSV,4.1MM,SBM,11.5 | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1260102 | 00889024019232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |