| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TI OBA PLATE ANCHOR DOMED DESIGN 5 HOLES | IMPLANT, ENDOSSEOUS, ORTHODONTIC | SYNTHES ELMIRA | OAT | 04.500.016 | 7533033 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-02 | 0 | 1. R |
Patient 1
ADDITIONAL INFORMATION: REVISION SURGERY WAS PERFORMED ON (B)(6) 2015. ONLY THE HARDWARE WHICH WAS CONFIRMED TO BE LOOSE WAS EXPLANTED FROM THE PATIENT. THE EXPLANTED HARDWARE INCLUDES (B)(4) PLATES (PART NUMBER 04.500.016), (B)(4) SCREWS (PART NUMBER 04.500.026.01) AND ONE SCREW (PART NUMBER 04.500.024.01). NO COMPLAINT IS ALLEGED AGAINST THE REMAINING HARDWARE.
Patient 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER, 04.500.016, ANCHOR T-PLATE, 5-HOLE, DOMED HEAD, ORTHODONTIC BONE ANCHOR SYSTEM, LOT NUMBER 7533033). THE SUBJECT DEVICE WAS RETURNED IN GOOD CONDITION. THE RETURNED PLATE HAS BEEN CONTOURED AND CUT WITH MINOR COSMETIC DAMAGE WHICH INDICATES THAT THE PLATE WAS ONCE IMPLANTED. 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. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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 3 OF 16 FOR (B)(4).
Patient 1
ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. EVENT DATE: UNKNOWN. DEVICE IS PLANNED TO BE EXPLANTED ON JUNE 05, 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
A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7533033 OF OBA PLATE ANCHOR DOMED DESIGN 5 HOLES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD DETERMINED THE RAW MATERIAL LOT 7126842 WAS ACCEPTED UNDER A NON-CONFORMANCE REPORT (NCR) FOR PITTING AND HIGH SURFACE FINISH. THERE ARE NO INDICATIONS THAT THE NCR ISSUE WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A DEVIATION WAS APPLIED TO THE RAW MATERIAL ACCEPTING BILLETS AT A REDUCED LENGTH TO RESOLVE BILLET FLATNESS CONCERNS. THERE IS NO INDICATION THE DEVIATED PRODUCT CONTRIBUTED TO THE COMPLAINT CONDITION. 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
SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND CURRENTLY PENDING COMPLETION. 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.