PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM
Report
- Report Number
- 0001032347-2019-00001
- Event Type
- Injury
- Date Received
- January 2, 2019
- Date of Event
- December 13, 2018
- Report Date
- April 23, 2019
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HRS
- PMA / PMN Number
- K972420
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. MEDICAL PRODUCT: BIOMET MICROFIXATION PECTUS SYSTEM ELONGATED STABILIZER TITANIUM CATALOG #: 01-3802 LOT #: NI THERAPY DATE: DEC 13, 2018 CORRECTED INFORMATION: G3 FOREIGN COUNTRY CORRECTED FROM NETHERLANDS TO FRANCE G5 PMA/510(K) NUMBER WAS CORRECTED FROM K972420 TO K061384 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2019-00061.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PATIENT SCANS, DESIGN INPUT FORM (DIF) AND EVIDENCE THAT A REVISION WAS PERFORMED. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PARTS NOT BEING RETURNED. ALSO, THERE WERE NO PHOTOGRAPHS, X-RAYS, OR PHYSICIAN REPORTS PROVIDED. BASED ON THE INFORMATION PROVIDED, THE SURGEON CONFIRMED THE ORIGINAL 12" BAR SIZE BY APPROVING THE DESIGN BASED ON THE PATIENT'S SCANNED ANATOMY. HOWEVER, THE BAR WAS DESIGNED ON 15 MONTH OLD SCANS (BAR DIF RECEIVED IN SEP 2018 AND SCAN DATED 26 JUN 2017). BASED ON THE AGE OF THE PATIENT AT THE TIME OF THE SCAN (16 YEARS OLD) IT IS POSSIBLE THAT SHE HAD NOT REACHED SKELETAL MATURITY WHICH COULD LEAD TO POTENTIAL CHANGES IN ANATOMY AT THE TIME OF IMPLANTATION. ALSO, SINCE THE NEW BAR IMPLANTED WAS 12.5", ANOTHER POTENTIAL CAUSE COULD BE THE ORIGINAL BAR WAS PLACED TOO FAR SUPERIOR OR INFERIOR TO THE LOCATION USED IN THE DESIGN. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. THE FOLLOWING FIELDS WERE UPDATED: DATE OF THIS REPORT, DESCRIBE EVENT OR PROBLEM, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, FOLLOW UP TYPE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00061-1.
IT WAS REPORTED THE FIRST IMPLANTED BAR AND STABILIZER WERE REMOVED AND A NEW PRE-BENT 12.5 INCH TITANIUM BAR AND STABILIZER WERE IMPLANTED. THE PROCEDURE WENT WELL. THE SURGEON STATED THE REASON FOR THE BAR MIGRATION IS THAT THE BAR WAS TOO SHORT FOR THE PATIENT.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
(B)(4). REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS 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 WAS REPORTED A REVISION WILL OCCUR DUE TO A PECTUS BAR MIGRATION. THE SURGEON PLANS TO ADD ANOTHER TITANIUM PECTUS BAR TO PROVIDE INCREASED STABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1421 | PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM | PLATE, FIXATION, BONE | HRS | BIOMET MICROFIXATION | N/A | 857000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Hospitalization| R |