| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TI OBA PLATE ANCHOR SCREW SELF-DRILLING 4MM | IMPLANT, ENDOSSEOUS, ORTHODONTIC | SYNTHES USA | OAT | 04.500.024.01 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-02 | 0 | 1. R |
Patient 1
PATIENT WAS BEING TREATED WITH ORTHODONTIC BONE ANCHORS (OBA). ON FOLLOW UP VISIT, SURGEON NOTICED TWO (2) OBA PLATES IN MAXILLA WERE BECOMING LOOSE. SURGEON BROUGHT PATIENT BACK TO HIS OFFICE WHERE HE REMOVED HARDWARE IN MAXILLA AND REPLACED IT WITH NEW OBA PLATES AND SCREWS. PROCEDURE WAS DONE ON 6/5/15. THERE WAS NO SURGICAL DELAY. PATIENT IS DOING WELL. THIS IS REPORT 17 OF 17 FOR (B)(4).
Patient 1
ADDITIONAL NARRATIVE: PATIENT WEIGHT IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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
AFTER ADDITIONAL INVESTIGATION, IT WAS DETERMINED THAT THIS DEVICE 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 THE MEDWATCH REPORTS FOR THIS DEVICE ARE HEREBY RESCINDED.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, 04.500.024.01, WAS NOT ASSOCIATED WITH THE REPORTED EVENT. THE MEDWATCH REPORTS FOR THIS DEVICE ARE HEREBY RESCINDED.
Patient 1
A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER, 04.500.024.01, 1.55MM MIDFACE SELF-DRILLING SCREW, LOT NUMBER UNKNOWN). THE SUBJECT DEVICE WAS RETURNED IN GOOD CONDITION WITH NO FUNCTIONAL DAMAGE AND ONLY MINOR MARRING AROUND THE HEX DRIVE. DUE TO THE NATURE OF THE COMPLAINT, THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED OR VERIFIED. THE CAUSE OF THE COMPLAINT CONDITION COULD NOT BE DETERMINED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS UNCONFIRMED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.