1.85MM TI MATRIX SCREW SELF-TAPPING/5MM
Report
- Report Number
- 8030965-2019-64802
- Event Type
- Injury
- Date Received
- June 3, 2019
- Date of Event
- January 1, 2019
- Report Date
- May 5, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- JEY
- UDI-DI
- 07611819358126
- PMA / PMN Number
- K083388
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D10: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE PLATES AND SCREWS HAVE BEEN RETAINED BY CUSTOMER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE SCREW DELIVERED FROM SYNTHES TO CUSTOMER (THROUGH MATERIALISE) ARE ALL DELIVERED IN AN UNSTERILE CONDITION. BASED ON THIS NO INVESTIGATION WILL BE DONE ON THOSE FROM SYNTHES SIDE. WE HAVE FORWARDED THE RECEIVED INFORMATION TO THE MATERIALISE FOR INVESTIGATION, AS THEY ARE RESPONSIBLE FOR DEVELOPMENT OF PLATE AND SCREW CONNECTION, FIND THE STATEMENT BELOW: RESULTS: FOR THIS COMPLAINT, THE DESIGN AND MANUFACTURING ASPECTS WERE INVESTIGATED FOR BOTH PLATES. THE BSSO PLATES WERE DESIGNED ACCORDING TO THE WORK INSTRUCTIONS. THE MEASUREMENTS TAKEN TO CONTROL THE PLANNING ASPECTS WERE ALL WITHIN THE SPECIFICATIONS. AS SUCH THE POSITION OF THE PLATES WAS PLANNED CORRECTLY. THE IMPLANT DESIGN ALSO MET SPECIFICATIONS AS THE THICKNESS AND WIDTH WERE ACCORDING TO THE WORK INSTRUCTIONS. THE SCREWS WERE PLACED MORE THAN 3.5MM APART FROM EACH OTHER AND THEREFORE THIS PART OF THE DESIGN ALSO MET SPECIFICATIONS. THE MECHANICAL ASPECTS OF THE DESIGN WERE ALSO INVESTIGATED. IT WAS FOUND THAT THE DIMENSIONS AND MECHANICAL PROPERTIES OF THE BSSO PLATES WERE ACCORDING TO DESIGN AND SPECIFICATIONS. THEREFORE NO ROOT CAUSE WAS FOUND FOR THE INFECTION. IN THE CAPA PROCESS CHANGES WERE ALREADY INVESTIGATED. NO CHANGES WERE FOUND THAT COULD INFLUENCE DESIGN OR BIOCOMPATIBILITY OF THE DEVICES. INFECTIONS CAN OCCUR DUE TO NON-DEVICE RELATED REASONS SUCH AS INADEQUATE WOUND CLOSURE (ORIGINALLY INDICATED BY SURGEON). HOWEVER, THIS CANNOT BE CONFIRMED NOR EXCLUDED BASED ON THE AVAILABLE INFORMATION AND IT DOES NOT EXPLAIN THE OTHER INFECTION COMPLAINTS. ROOT CAUSE PROCESS CATEGORY: ROOT CAUSE NOT FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
7/10/2019 UPDATED EVENT DESCRIPTION (ADDITIONAL INFORMATION) IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL SURGERY DUE TO INFECTION ON (B)(6) 2019. ORIGINALLY, THE PATIENT HAD BI SAGITTAL SPLIT OSTEOTOMY OF THE MANDIBLE AND WAS IMPLANTED WITH THE TRUMATCH TITANIUM (TI) MIDFACE MANDIBLE PLATE AND FORTY-SIX (46) MATRIX SCREWS ON (B)(6) 2019. ON (B)(6) 2019, A PATIENT PRESENTED WITH AN INFECTION AT THE RIGHT SIDE OF THE MANDIBLE WHEREIN A SWAB WAS TAKEN WITH AN UNKNOWN RESULT. THE PATIENT WAS ON AN ANTIBIOTICS THERAPY. THE IMPLANTS WERE NOT REPLACED. THE SURGERY WAS COMPLETED WITH THE PATIENT IN STABLE CONDITION. PLEASE SEE THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL THIRTY-SEVEN DEVICES. THIS COMPLAINT INVOLVES TEN (10) DEVICES.
DATE OF EVENT-UNKNOWN DATE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, A PATIENT PRESENTED WITH AN INFECTION AT THE RIGHT SIDE OF THE MANDIBLE WHEREIN THE SWAB WAS TAKEN ITH UNKNOWN RESULT. THE PATIENT HAD A BI SAGITTAL SPLIT OSTEOTOMY OF THE MANDIBLE AND WAS IMPLANTED WITH THE TRUMATCH TITANIUM (TI) MIDFACE MANDIBLE PLATE AND FORTY-SIX (46) MATRIX SCREWS ON (B)(6) 2019. PATIENT WAS ON AN ANTIBIOTICS THERAPY. THE PATIENT IS SCHEDULED FOR REMOVAL OF PLATE AND SCREWS ON (B)(6) 2019. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 10 OF 47 DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL THIRTY-SEVEN DEVICES DOCUMENTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455140 | 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM | BONE PLATE | JEY | OBERDORF SYNTHES PRODUKTIONS GMBH | 07611819358126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |