BIOHORIZONS ABUTMENT
Report
- Report Number
- 1060818-2021-12027
- Event Type
- Malfunction
- Date Received
- November 10, 2021
- Report Date
- October 29, 2021
- Manufacturer
- BIOHORIZONS IMPLANT SYSTEMS
- Product Code
- NHA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THERE ARE A TOTAL OF FOUR (4) MALFUNCTIONED EVENTS. ALL FOUR (4) UNITS WERE RETURNED FOR INVESTIGATIONS. 3 OF THE 4 UNITS RETURNED SHOWED THE ABUTMENT FUNCTIONING AS DESIGNED. 1 OF THE 4 UNITS DID NOT HAVE PRODUCT RETURNED. THEREFORE, NO CONCLUSION MAY BE DRAWN TO THE CAUSE. UPDATED INFORMATION: THE ORIGINAL FILE WAS SENT ON (B)(6) 2021 FOR 3RD QUARTER 2021. THE DETAILS FOR REPORT NUMBER 1060818-2021-12027 WERE PREVIOUSLY SUBMITTED ON (B)(6) 2021. THE ORIGINAL REPORT WAS ACCIDENTALLY OVERWRITTEN ON (B)(6) 2021 WHEN A SINGLE MDR EVENT DATED (B)(6 2021 FOR COMPLAINT (B)(4) WAS PROCESSED, KEYED, AND TRANSMITTED. THE SINGLE MDR EVENT FOR COMPLAINT (B)(4) SHOULD HAVE NOT BEEN ASSIGNED 1060818-2021-12027 BECAUSE 1060818-2021-12027 HAD ALREADY BEEN USED AND TRANSMITTED. REPORT NUMBER 1060818-2021-12027 WAS ORIGINALLY SLATED FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT COVERING FRACTURED HEX ABUTMENTS. MFR REPORT NUMBER 1060818-2021-15681 WAS CREATED TO ALLOW FOR THE CORRECTION OF THE SINGLE MDR EVENT ASSOCIATED WITH COMPLAINT NUMBER (B)(4). OVERALL, THE SUBMISSION OF 1060818-2021-12027 IS TO CORRECT AND REINSTATE REPORT 1060818-2021-12027 WHICH WAS OVERWRITTEN IN ERROR ON (B)(6) 2021.
THERE ARE A TOTAL OF FOUR (4) MALFUNCTION EVENTS. ALL FOUR (4) UNITS WERE RETURNED FOR INVESTIGATIONS. -3 OF THE 4 EVENTS RETURNED SHOWED THE ABUTMENT FUNCTIONING AS DESIGNED. 1 OF THE EVENTS DID NOT HAVE PRODUCT RETURNED FOR INVESTIGATION. THEREFORE, NO CONCLUSION MAY BE DRAWN TO THE CAUSE. UPDATED INFORMATION: THE ORIGINAL FILE WAS SENT ON 10/29/2021 FOR 3RD QUARTER 2021. THE DETAILS FOR REPORT NUMBER 1060818-2021-12027 WERE PREVIOUSLY SUBMITTED ON 10/29/2021. THE ORIGINAL REPORT WAS ACCIDENTALLY OVERWRITTEN ON 11/10/2021 WHEN A SINGLE MDR EVENT DATED (B)(6) 2021 FOR COMPLAINT (B)(4) WAS PROCESSED, KEYED, AND TRANSMITTED. THE SINGLE MDR EVENT FOR COMPLAINT (B)(4) SHOULD HAVE NOT BEEN ASSIGNED 1060818-2021-12027 BECAUSE 1060818-2021-12027 HAD ALREADY BEEN USED AND TRANSMITTED. REPORT NUMBER 1060818-2021-12027 WAS ORIGINALLY SLATED FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT COVERING ABUTMENTS EXPERIENCING OPERATIONAL ISSUES. MFR REPORT NUMBER 1060818-2021-15681 WAS CREATED TO ALLOW FOR THE CORRECTION OF THE SINGLE MDR EVENT ASSOCIATED WITH COMPLAINT NUMBER (B)(4). OVERALL, THE SUBMISSION OF 1060818-2021-12027 IS TO CORRECT AND REINSTATE REPORT 1060818-2021-12027 WHICH WAS OVERWRITTEN IN ERROR ON 11/10/2021. UPDATED INFORMATION FOR FOLLOW UP #2. THIS FOLLOW UP IS TO REATTACH THE PROBLEM CODE OF 1384 TO THE FILE. THE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM IS RARELY PROVIDED DURING THE COLLECTION OF INFORMATION FOR THE REPORTED MALFUNCTION. THEREFORE, CODE 4648 IS BEING USED IN H6 - HEALTH EFFECT - IMPACT CODE. CODE 4756 WITHIN THE COMPONENT CODE SECTION OF H6 IS BEING USED BECAUSE NO OTHER CODE WITHIN ANNEX G IS COMPATIBLE WITH PRO CODES NHA OR NDP.
THERE ARE A TOTAL OF FOUR (4) MALFUNCTION EVENTS. ALL FOUR (4) UNITS WERE RETURNED FOR INVESTIGATIONS. -3 OF THE 4 EVENTS RETURNED SHOWED THE ABUTMENT FUNCTIONING AS DESIGNED. 1 OF THE EVENTS DID NOT HAVE PRODUCT RETURNED FOR INVESTIGATION. THEREFORE, NO CONCLUSION MAY BE DRAWN TO THE CAUSE. UPDATED INFORMATION THE ORIGINAL FILE WAS SENT ON 10/29/2021 FOR 3RD QUARTER 2021. THE DETAILS FOR REPORT NUMBER 1060818-2021-12027 WERE PREVIOUSLY SUBMITTED ON 10/29/2021. THE ORIGINAL REPORT WAS ACCIDENTALLY OVERWRITTEN ON 11/10/2021 WHEN A SINGLE MDR EVENT DATED 10/11/2021 FOR COMPLAINT (B)(4) WAS PROCESSED, KEYED, AND TRANSMITTED. THE SINGLE MDR EVENT FOR COMPLAINT (B)(4) SHOULD HAVE NOT BEEN ASSIGNED 1060818-2021-12027 BECAUSE 1060818-2021-12027 HAD ALREADY BEEN USED AND TRANSMITTED. REPORT NUMBER 1060818-2021-12027 WAS ORIGINALLY SLATED FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT COVERING ABUTMENTS EXPERIENCING OPERATIONAL ISSUES. MFR REPORT NUMBER 1060818-2021-15681 WAS CREATED TO ALLOW FOR THE CORRECTION OF THE SINGLE MDR EVENT ASSOCIATED WITH COMPLAINT NUMBER (B)(4) . OVERALL, THE SUBMISSION OF 1060818-2021-12027 IS TO CORRECT AND REINSTATE REPORT 1060818-2021-12027 WHICH WAS OVERWRITTEN IN ERROR ON 11/10/2021. UPDATED INFORMATION FOR FOLLOW UP #2. THIS FOLLOW UP IS TO REATTACH THE PROBLEM CODE OF 1384 TO THE FILE. THE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM IS RARELY PROVIDED DURING THE COLLECTION OF INFORMATION FOR THE REPORTED MALFUNCTION. THEREFORE, CODE 4648 IS BEING USED IN H6 - HEALTH EFFECT - IMPACT CODE. CODE 4756 WITHIN THE COMPONENT CODE SECTION OF H6 IS BEING USED BECAUSE NO OTHER CODE WITHIN ANNEX G IS COMPATIBLE WITH PRO CODES NHA OR NDP.
THERE WAS A TOTAL OF 4 MALFUNCTIONED EVENTS ASSOCIATED WITH A ABUTMENT PERFORMANCE ISSUES. 3 OF THE 4 UNITS RETURNED SHOWED THE ABUTMENT FUNCTIONED AS DESIGN. 1 OF THE 4 UNITS DID NOT HAVE PRODUCT RETURNED. THEREFORE, NO CONCLUSION MAY BE DRAWN. ITEMS INVOLVED- BIOHORIZONS UNKNOWN, PROSTHETIC, MULTI-UNIT ABUTMENT.
THIS REPORT SUMMARIZES FOUR 4 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED ABUTMENT WITH OPERATIONAL ISSUES. THE REPORT WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED ABUTMENTS WITH OPERATIONAL ISSUES. THE REPORT WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED ABUTMENTS WITH OPERATIONAL ISSUES. THE REPORT WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED ABUTMENT OPERATION ISSUES. THE REPORT WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING THE PATIENT DEMOGRAPHICS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1682813 | BIOHORIZONS ABUTMENT | CUSTOM CAST - MULTI-UNIT ABUTMENT | NHA | BIOHORIZONS IMPLANT SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |