IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
Report
- Report Number
- 0002023141-2023-03100
- Event Type
- Injury
- Date Received
- November 1, 2023
- Date of Event
- August 22, 2023
- Report Date
- May 22, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019263
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. CORRECTION: BRAND NAME WAS UPDATED FROM 'IMP,TSV,4.1MM,SBM,8' TO 'IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM'; CATALOG NUMBER WAS UPDATED FROM 'TSV4B8' TO 'TSVB11'; LOT NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) NUMBER AND DEVICE MANUFACTURE DATE WERE REMOVED; AND PMA/510(K) # WAS UPDATED FROM 'K072589' TO 'K061410'. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D1. BRAND NAME WAS CORRECTED. D4: CATALOG NUMBER WAS CORRECTED. D4: LOT NUMBER WAS REMOVED. D4: UNIQUE IDENTIFIER (UDI) NUMBER WAS REMOVED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K013227. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H4. DEVICE MANUFACTURE DATE WAS REMOVED. H10: NARRATIVE/DATA WAS UPDATED. H11: CORRECTED DATA WAS UPDATED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.
ZIMVIE COMPLAINT NUMBER (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 UPDATED TO REFLECT THE CORRECT DATE. NEW INFORMATION PROVIDED (ITEM REFERENCE) ON MAR 1, 2024. INVESTIGATION RESULTS COMPLETED ON MAR 28, 2024. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H10: ADDITIONAL NARRATIVE. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER ASSOCIATED TO THE ITEM WAS NOT PROVIDED. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE TSVB11 DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORD: PERI-IMPLANTITIS). A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.
THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. CORRECTION: BRAND NAME WAS UPDATED FROM 'IMP,TSV,4.1MM,SBM,8' TO 'IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM'; CATALOG NUMBER WAS UPDATED FROM 'TSV4B8' TO 'TSVB11'; LOT NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) NUMBER AND DEVICE MANUFACTURE DATE WERE REMOVED; AND PMA/510(K) # WAS UPDATED FROM 'K072589' TO 'K061410'.
NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT AFTER OSTEOINTEGRATION, THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANTS TOOTH SITES #8 AND #19, WITH ASSOCIATED ACUTE INFLAMMATION AND ABSCESS. THEREFORE, THE IMPLANTS WERE REMOVED.
NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1890074 | IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1252148 | 00889024019263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |