IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM
Report
- Report Number
- 0002023141-2022-00954
- Event Type
- Injury
- Date Received
- April 21, 2022
- Date of Event
- March 15, 2022
- Report Date
- April 29, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020092
- PMA / PMN Number
- K061410
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBERS WERE K011028 AND K013227.
SUPPLEMENTAL REPORT PROVIDED AS THE CUSTOMER PROVIDED ADDITIONAL INFORMATION INDICATING THE PATIENT'S CONDITION IMPROVED AFTER IMPLANT REMOVAL.
ONE IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM (TSVWH10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. MEASUREMENTS WERE TAKEN USING CAL3839 (DUE DATE: 02-SEP-2022). THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE HAS BEEN IDENTIFIED TO BE WITHIN SPECIFICATION (FILE: DRAWING). PRE-EXISTING CONDITIONS NOTED ON THE PER WAS MODERATE BONE DENSITY ¿ TYPE II. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #20 (UNIVERSAL) FOR ABOUT 18 DAYS. X-RAY & PICTURE EVALUATION: X-RAY/PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS & PRECAUTIONS. PER THE APPLICABLE IFU, IMPROPER TECHNIQUES OR PATIENT FACTORS SUCH AS SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE DEVICE FAILURE. DHR & STERILIZATION RECORDS REVIEW: DHR REVIEW FOR THE LOT: (1243138) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORDS WERE REVIEWED (OP120) AND NO ISSUES THAT COULD CONTRIBUTE TO THE REPORTED EVENT WAS IDENTIFIED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1243138) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: MEDICAL: OTHER) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT CONDITIONS WERE NONVERIFIABLE. SECTIONS UPDATED: B4: DATE OF THIS REPORT. G3: DATE INVESTIGATION RESULTS WERE RECEIVED. G6: TYPE OF REPORT AND FOLLOW UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED. H6: ADVERSE EVENT PROBLEM CODES. H10: MANUFACTURER'S NARRATIVE.
IT WAS REPORTED THAT THE PATIENT FELT ILL SINCE THE IMPLANT WAS PLACED WITH A FEVER. IMPLANT WAS REMOVED TO ELIMINATE IT AS A POSSIBLE ETIOLOGY.
THE CUSTOMER CLARIFIED THAT THE PATIENT IS HEALING WELL. SHE IS CONSIDERING HYPERSENSITIVITY TESTING TO TITANIUM.
THERE IS NO UPDATE TO THE COMPLAINT DESCRIPTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1769618 | IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVWH10 | 1243138 | 00889024020092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Required Intervention |