MPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
Report
- Report Number
- 0002023141-2023-01863
- Event Type
- Injury
- Date Received
- July 11, 2023
- Date of Event
- March 14, 2023
- Report Date
- December 27, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019508
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIZIMVIE RECEIVED ONE (1) TSVB10, (IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM) FOR EVALUATION (IMAGES ARE ATTACHED). VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, NO APPARENT MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. MARKINGS DUE TO THE REMOVAL PROCESS. CAL3845 DUE: 27 AUG 2024. 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. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250298. 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 1250298 FOR SIMILAR EVENTS AND ONE (1) OTHER COMPLAINT WAS IDENTIFIED (CE-03481-2023). REVIEW COMPLETED UTILIZING KEYWORDS: ¿ALLERGIC REACTION.¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS - 4869 REV. 9-10/19. INFORMATION IDENTIFIED: "ADVERSE EFFECTS" PAGE 2. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 3, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE MISSING OR CONFUSING INSTRUCTIONS FOR USE, MATERIAL SELECTION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS NON-VERIFIABLE WITH ALL THE AVAILABLE INFORMATION. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE
ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: K011028, K013227.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THERE WAS AN ALLERGIC REACTION. THE PATIENT CAME TO THE CLINIC DUE TO THE MISSING TOOTH OF LEFT UPPER 2 IN (B)(6) 2023. THE IMPLANTATION WAS PERFORMED AFTER EXAMINATION. THE ZIMMER TSV IMPLANT OF 3.7*10 WAS IMPLANTED. THE PATIENT REFLECTED THE IMPLANT SITE WAS RED AND SWOLLEN, ACCOMPANIED WITH SEVERE PAIN. THE PATIENT CAME TO THE CLINIC FOR EXAMINATION. THE ALLERGY WAS FOUND. THE IMPLANT WAS REMOVED UPON THE PATIENT¿S REQUEST. TOOTH SITE # 22. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771916 | MPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVB10 | 1250298 | 00889024019508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female |