PLATE, FIXATION, BONE
Report
- Report Number
- 2520274-2016-14365
- Event Type
- Injury
- Date Received
- August 26, 2016
- Report Date
- August 11, 2016
- Manufacturer
- SYNTHES (USA)
- Product Code
- HRS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR ONE UNKNOWN MATRIX RIB SCREW. OTHER NUMBER¿UDI: PART NUMBER UNKNOWN, UDI IS UNAVAILABLE. DEVICE HAS NOT BEEN REMOVED FROM PATIENT AS OF SUBMISSION DATE OF THIS REPORT. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION AT THIS TIME. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY. WITHOUT A VALID PART/LOT NUMBER, THE EXACT 510K NUMBER CANNOT BE CONFIRMED. HOWEVER, THE LIKELY VALUE IS K 133616. CORRECTED DATA: (X-RAY DATE CLARIFICATION), EXPLANT DATE. CONCOMITANT MEDICAL PRODUCTS: THE MATRIX RIB PLATE IS NO LONGER CONSIDERED CONCOMITANT. THE DEVICE HAS BEEN ADDED AS ITS OWN PART FORM ON THIS COMPLAINT. DEVICE 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.
IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE SURGEON'S OFFICE ON (B)(6) 2016 WITH THE COMPLAINT OF NEW PAIN. IT WAS REPORTED THAT AN X-RAY TAKEN IN THE SURGEON'S OFFICE SHOWED ONE OF THE MATRIX RIB PLATES THAT WAS IMPLANTED ON (B)(6) 2016 HAD A LOOSE SCREW, AND THE RIB WAS DISPLACED. A TREATMENT PLAN TO ADDRESS THIS ISSUE HAS NOT YET BEEN DETERMINED BY THE SURGEON. INITIALLY, THE PATIENT FELL AND SUSTAINED MULTIPLE RIB FRACTURES ON AN UNKNOWN DATE IN (B)(6) 2016. THE PATIENT WAS TREATED WITH PAIN MEDICATION. THE PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE IN (B)(6) 2016 COMPLAINING OF CONTINUED RIB PAIN AFTER HER INITIAL INJURY. X-RAYS AT THE TIME SHOWED NONUNION OF SEVERAL OF THE RIB FRACTURES. ON (B)(6) 2016 SURGERY WAS PERFORMED. A MATRIX RIB SET SYSTEM PLATE(S) AND AN UNKNOWN QUANTITY OF UNKNOWN SCREWS WERE IMPLANTED. THIS REPORT IS FOR ONE UNKNOWN MATRIX RIB SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).
ADDITIONAL CLARIFICATION: THE PATIENT WAS ORIGINALLY INJURED SOMETIME DURING (B)(6) 2016, WHEN THE SEVENTH, EIGHTH, NINTH, AND TENTH RIBS WERE FRACTURED. ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A RIB PLATE AND EIGHT (8) MATRIX RIB SCREWS ON AN UNKNOWN LEFT RIB. FOLLOWING REPORTS OF PAIN AT THE IMPLANT SITE, THE PATIENT UNDERWENT X-RAY IMAGING ON (B)(6) 2016. THE IMAGES SEEMED TO INDICATE THAT ONE (1) OF THE SCREWS HAD LOOSENED FROM THE PLATE, WHICH, IN TURN, CAUSED THE PLATE TO MOVE AWAY FROM THE BONE RESULTING IN A NON-UNION. ON (B)(6) 2016, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REVISION. DURING THE PROCEDURE, TWO (2) BROKEN PLATES AND AN UNKNOWN QUANTITY OF SCREWS WERE REMOVED. NON-UNION WAS ASSESSED AT TWO (2) OF THE RIBS. THE PATIENT WAS REVISED TO AN ILIAC BONE GRAFT ALONG WITH THE IMPLANTATION OF TWO (2) TITANIUM MATRIX RIB PLATES AND SIXTEEN (16) UNKNOWN SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF DELAY OR PATIENT HARM. CONCOMITANT DEVICE(S) REPORTED: SCREW (PART/LOT/QUANTITY: UNKNOWN). THIS REPORT IS 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557674 | PLATE, FIXATION, BONE | HRS | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |