IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
Report
- Report Number
- 0002023141-2024-03064
- Event Type
- Malfunction
- Date Received
- September 26, 2024
- Report Date
- January 29, 2025
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019515
- PMA / PMN Number
- K061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMVIE 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. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS. TSVB10, IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM, LOT 1261974. TSVB11, IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM LOT 1264279. TSX31B8, TSX IMPLANT, 3.1MMD, 8MML LOT 1259848. TSX31B8, TSX IMPLANT, 3.1MMD, 8MML LOT 1261974. TSV4B10, IMP,TSV,4.1MM,SBM,10 LOT 1261280. TSV4B11, IMP,TSV,4.1MM,SBM,11.5 LOT 1262306. TSV4B13, IMP,TSV,4.1MM,SBM,13 LOT 1260099. TSVB11, IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM LOT 1264279 X 3. TSVB11, IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM LOT 1260333 X 2. TSV4B11, IMP,TSV,4.1MM,SBM,11.5 LOT 1262306 X 2. G4: PREMARKET IDENTIFICATION K013227. D10. THERAPY DATE UNKNOWN.
ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) TSVB11, (IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT OUTER PACKAGING WAS ALREADY OPENED. THE IMPLANT OUTER VIAL HAS A CRACKED GREEN CAP, AND THE OUTER VIAL TAMPER SEAL WAS INTACT. THE COOB IS CONFIRMED. 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. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1264279. 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 1264279 FOR SIMILAR EVENTS AND FOUR (4) OTHER COMPLAINTS WERE IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: PACKAGING DAMAGED. THE CUSTOMER DID SUBMIT FOUR (4) IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND ACCORDING TO THE CAPA, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS EXTERNAL FACTORS (TEMPERATURE). THIS IS AN ONGOING ISSUE WHICH IS CURRENTLY BEING MONITORED. NON CONFORMANCE AND HEALTH HAZARD EVALUATION HAVE BEEN OPENED TO FURTHER CONTAIN AFFECTED PRODUCTS, EVALUATE POTENTIAL ROOT CAUSES, AND CONSIDER APPLICABLE CORRECTIVE ACTIONS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A PACKAGING MALFUNCTION DID OCCUR. THE IMPLANT'S GREEN CAP WAS CRACKED WHILE THE GREEN CAPS TAMPER SEAL WAS INTACT. THE REPORTED EVENT/COOB WAS CONFIRMED. 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.
DOCTOR REPORTED THAT IN THE LAST ORDER THEY RECEIVED THERE WERE SOME IMPLANTS WITH A CRACKED CAP. DOCTOR NOTICED AT THE TIME OF SURGERY AND IMPLANTS WERE CHANGED BY DISTRIBUTOR FOR NEW ONES. NO PATIENT IMPACT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1304211 | IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1264279 | 00889024019515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | DENTAL IMPLANT |