FLAT TITANIUM PECTUS BAR 11IN
Report
- Report Number
- 0001032347-2025-00009
- Event Type
- Injury
- Date Received
- January 9, 2025
- Report Date
- June 4, 2025
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HRS
- UDI-DI
- 00841036179106
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
COMPLAINT (B)(4). G2: FOREIGN SOURCE: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO K212841. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, D4, G3, G6, H2, H3, H4, H6, H10 AND H11.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 ¿ MEDICAL PRODUCTS ITEM# JP-0110, LOT# 66720980, FLAT TITANIUM PECTUS BAR 11IN THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS A1, B4, B5, D4, D6, D10, G3, G6, H2, H11.
IT IS REPORTED THAT THE PATIENT UNDERWENT A PECTUS BAR IMPLANTATION FOR FUNNEL CHEST TREATMENT. SUBSEQUENTLY AFTER HOSPITAL DISCHARGE, THE PATIENT WAS SEEN AT AN OUTPATIENT CLINIC ON AN UNKNOWN DATE WITH FEVER DUE TO UNKNOWN REASONS. PATIENT RECEIVED STEROIDS AND RECOVERED WELL.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT IS REPORTED THAT THE PATIENT UNDERWENT A PECTUS BAR IMPLANTATION FOR FUNNEL CHEST TREATMENT. SUBSEQUENTLY ONE WEEK AFTER HOSPITAL DISCHARGE, THE PATIENT WAS SEEN AT AN OUTPATIENT CLINIC WITH FEVER DUE TO UNKNOWN REASONS. PATIENT RECEIVED ANTIBIOTIC PREDNISONE AND RECOVERED WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379358 | FLAT TITANIUM PECTUS BAR 11IN | PLATE, FIXATION, BONE | HRS | BIOMET MICROFIXATION | N/A | 66708434 | 00841036179106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | SEE H11. |