| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES | IMPLANT, ENDOSSEOUS, ORTHODONTIC | SYNTHES USA | OAT | 04.500.013 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-02 | 0 | 1. R |
Patient 1
IT WAS REPORTED THAT WHEN THE PATIENT CAME IN FOR FOLLOW UP, THE SURGEON NOTED ORTHODONTIC BONE ANCHOR (OBA) PLATE AND SCREW CONSTRUCT IS LOOSE. SURGEON IS PLANNING TO REMOVE IMPLANTS ON (B)(6) 2015 AND REPLACE WITH NEW IMPLANTS. THIS IS REPORT 2 OF 16 FOR (B)(4).
Patient 1
ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. EVENT DATE: UNKNOWN. DEVICE IS PLANNED TO BE EXPLANTED ON (B)(6) 2015, BUT HAS NOT BEEN EXPLANTED YET. 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. 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.
Patient 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AFTER ADDITIONAL INVESTIGATION, IT WAS DETERMINED THAT PART NUMBER 04.500.013 WAS NOT ASSOCIATED WITH THE REPORTED EVENT. THE MEDWATCH REPORTS FOR THIS DEVICE ARE HEREBY RESCINDED. THE PREVIOUS MEDWATCH REPORTS FOR THIS DEVICE WERE SUBMITTED IN ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Patient 1
ADDITIONAL INFORMATION WAS OBTAINED AFTER THIS COMPLAINT FILE WAS RE-REVIEWED AND FURTHER CLARIFICATION OF THE DEVICES INVOLVED IN THE REPORTED EVENT WERE OBTAINED FROM THE REPORTER ON JULY 16, 2015. ADDITIONAL DEVICES, WHICH WERE NOT RELATED TO THIS COMPLAINT, WERE MISTAKENLY REPORTED AND/OR RETURNED WITH THE ACTUAL COMPLAINED DEVICES FOR (B)(4). AFTER ADDITIONAL INVESTIGATION, IT WAS DETERMINED THAT PART NUMBER, 04.500.013, WAS NOT ASSOCIATED WITH THE REPORTED EVENT. THE MEDWATCH REPORTS FOR THIS DEVICE ARE HEREBY RESCINDED.
Patient 1
A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2015. THIS PART WAS NOT ONE OF THE EXPLANTED DEVICES. (B)(4). 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.
Patient 1
UPDATE: IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH ORTHODENTIC BONE ANCHORS (OBA). DURING A FOLLOW UP VISIT, THE SURGEON NOTICED THAT TWO (2) OBA PLATES IN MAXILLA WERE BECOMING LOOSE. THE SURGEON BROUGHT THE PATIENT BACK TO HIS OFFICE WHERE HE REMOVED THE HARDWARE IN MAXILLA (TWO PLATES AND SIX SCREWS) AND REPLACED IT WITH NEW OBA PLATES AND SCREWS. THE REVISION PROCEDURE WAS SUCCESSFULLY PERFORMED ON (B)(6) 2015 WITH NO SURGICAL DELAY NOTED. THE PATIENT IS DOING WELL.