"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
Report
- Report Number
- 0001032347-2018-00526
- Event Type
- Injury
- Date Received
- August 3, 2018
- Report Date
- July 15, 2019
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- PMA / PMN Number
- PK121589
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00215-1 & 0001032347-2019-00216-1.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: BIOMET MICROFIXATION HIGH TORQUE CROSS-DRIVE SCREW, CATALOG #: 91-1513 LOT #: UNK; BIOMET MICROFIXATION HIGH TORQUE CROSS-DRIVE SCREW, CATALOG # 91-1515 LOT #: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00215 & 0001032347-2019-00216.
REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DISTRIBUTOR REPORTED THAT THE PATIENT DEVELOPED AN INFECTION APPROXIMATELY ONE WEEK POST-OPERATIVELY. THE DISTRIBUTOR ALSO REPORTED THAT THE TYPE OF INFECTION WAS UNKNOWN, THE INFECTION WAS TREATED WITH ANTIBIOTICS, AND THERE ARE NO PLANS TO REVISE. NO PRODUCT WAS RETURNED AS THE PRODUCT REMAINS IMPLANTED. NO INSPECTIONS OR TESTING COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIANS REPORTS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE TYPE OR CAUSE OF THE INFECTION. FOR THESE REASONS, THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THE IMPLANTS IN THIS COMPLAINT ARE PROVIDED UNSTERILE AND ARE MEANT TO BE STERILIZED BY THE FACILITY UPON RECEPTION OF THE PRODUCT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART NUMBERS AND LOT NUMBERS OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXFORD PERFORMANCE MATERIALS (OPM) HTR-PEKK HENRIKSEN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANT, CATALOG #: PK620898, LOT #: 060818; OXFORD PERFORMANCE MATERIALS (OPM) HTR-PEKK HENRIKSEN RTIGH MAXILLA IMPLANT, CATALOG #: PK620905, LOT #: 060818. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION; IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT IS REPORTED THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY ONE (1) WEEK AFTER IMPLANTATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION RESOLVED. THERE IS NO REVISION PLANNED. THERE IS NO KNOWN HISTORY OF INFECTION AT THE FACILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589869 | "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW | SCREW, BONE | JEY | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |