CERAMENT BONE VOID FILLER
Report
- Report Number
- 3005304945-2024-00003
- Event Type
- Injury
- Date Received
- April 26, 2024
- Date of Event
- January 24, 2024
- Report Date
- March 29, 2024
- Manufacturer
- BONESUPPORT AB
- Product Code
- MQV
- UDI-DI
- 07350055430035
- PMA / PMN Number
- K201535
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MLOT0983 (A0210-08, CERAMENT BONE VOID FILLER), MANUFACTURING DATE:10/20/2022, EXPIRATION DATE: 12/11/2025. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT0983 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN 10/31/2022, (B)(4) DEVICES OF THE TOTAL BATCH SIZE OF (B)(4) DEVICES HAVE BEEN SOLD. THE MEDICAL INVESTIGATION OF THE COMPLAINT WILL BE SUBMITTED IN A FOLLOW-UP REPORT AFTER RECIEVING ADDITIONAL DATA FROM THE RESPONSIBLE PHYSICIAN. THIS INFORMATION WAS ADDED ON 19TH JUNE 2024: ADDITIONAL INFORMATION WAS RECEIVED FROM THE SUREGON 24TH APRIL 2024, THEREAFTER A MEDICAL INVESTIGATION WAS PERFORMED. CONCLUSION OF THE MEDICAL DEVICE: THE INFORMATION TO THIS COMPLAINT IS SUFFICIENT TO DRAW SOME CONCLUSIONS. THE REPORTED CASE IS OFF LABEL USE SINCE THE AGE OF THE PATIENT LESS THAN 9 YEARS OLD. "WHITE DRAINAGE" IS A WELL-KNOWN OCCURRENCE IN CALCIUM-BASED BONE VOID FILLERS. THE INCIDENT CONSIDERED IS AN EXPECTED AND FORESEEABLE EFFECT WHICH WAS DESCRIBED IN THE RISK ASSESSMENT AND IN THE INSTRUCTIONS FOR USE FOR CERAMENT BONE VOID FILLER. USUALLY, SURGICAL REVISION IS NOT NECESSARY IN THE ABSENCE OF SIGNS OF RECURRENT INFECTION. HOWEVER, IN THIS CASE THE WOUND WAS INFECTED, AND REOPERATION NEEDED. WE ALSO RECEIVED INFORMATION THAT THE WOUND HEALED. SEE ATTACHMENT FOR COMPLETE MEDICAL INVESTIGATION REPORT. THIS INFORMATION WAS ADDED ON THE 10TH JULY 2024: INVESTIGATIONS ARE STILL ONGOING AT BONESUPPORT WITHIN CAPA-0166 AS REFERRED ABOVE.
MLOT0983 (A0210-08, CERAMENT BONE VOID FILLER), MANUFACTURING DATE:10/20/2022, EXPIRATION DATE: 12/11/2025. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT0983 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN 10/31/2022, (B)(4) DEVICES OF THE TOTAL BATCH SIZE OF (B)(4) DEVICES HAVE BEEN SOLD. THE MEDICAL INVESTIGATION OF THE COMPLAINT WILL BE SUBMITTED IN A FOLLOW-UP REPORT AFTER RECIEVING ADDITIONAL DATA FROM THE RESPONSIBLE PHYSICIAN.
MLOT0983 (A0210-08, CERAMENT BONE VOID FILLER), MANUFACTURING DATE:10/20/2022, EXPIRATION DATE: 12/11/2025. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT0983 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN 10/31/2022, (B)(4) DEVICES OF THE TOTAL BATCH SIZE OF (B)(4) DEVICES HAVE BEEN SOLD. THE MEDICAL INVESTIGATION OF THE COMPLAINT WILL BE SUBMITTED IN A FOLLOW-UP REPORT AFTER RECEIVING ADDITIONAL DATA FROM THE RESPONSIBLE PHYSICIAN. THIS INFORMATION WAS ADDED ON 19TH JUNE 2024: ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON 24TH APRIL 2024, THEREAFTER A MEDICAL INVESTIGATION WAS PERFORMED. CONCLUSION OF THE MEDICAL DEVICE: THE INFORMATION TO THIS COMPLAINT IS SUFFICIENT TO DRAW SOME CONCLUSIONS. THE REPORTED CASE IS OFF LABEL USE SINCE THE AGE OF THE PATIENT LESS THAN 9 YEARS OLD. "WHITE DRAINAGE" IS A WELL-KNOWN OCCURRENCE IN CALCIUM-BASED BONE VOID FILLERS. THE INCIDENT CONSIDERED IS AN EXPECTED AND FORESEEABLE EFFECT WHICH WAS DESCRIBED IN THE RISK ASSESSMENT AND IN THE INSTRUCTIONS FOR USE FOR CERAMENT BONE VOID FILLER. USUALLY, SURGICAL REVISION IS NOT NECESSARY IN THE ABSENCE OF SIGNS OF RECURRENT INFECTION. HOWEVER, IN THIS CASE THE WOUND WAS INFECTED, AND REOPERATION NEEDED. WE ALSO RECEIVED INFORMATION THAT THE WOUND HEALED. SEE ATTACHMENT FOR COMPLETE MEDICAL INVESTIGATION REPORT.
THE ROOT-CAUSE INVESTIGATION CONCLUDED THAT DEVIATIONS WERE MADE FROM IFU0007-12 FOR THIS CASE. THE INDICATION FOR CERAMENT BVF (SEE IFU0007) IS: CERAMENT®/BONE VOID FILLER IS INDICATED TO BE INJECTED, OR PLACED, INTO BONY VOIDS OR GAPS IN THE SKELETAL SYSTEM, I.E. EXTREMITIES, PELVIS, AND POSTEROLATERAL SPINE (ONLY DURING OPEN SURGERY IN SPINE). THESE DEFECTS MAY BE THE RESULT OF BENIGN BONE CYSTS AND TUMORS (IN ADULTS AND PEDIATRIC PATIENTS 9-YEARS OLD AND OLDER), OR OSSEOUS DEFECTS CREATED AS A RESULT OF EITHER SURGERY OR TRAUMATIC INJURY TO THE BONE. IN THIS CASE THE PRODUCT WAS USED ON A 7-YEAR-OLD, HENCE THE PRODUCT HAS BEEN USED OFF-LABEL.
POST-OPERATIVELY THE INCISION HEALED NICELY THEN WEEKS LATER THE INCISION OPENED AND STARTED DRAINING LIQUID CERAMENT. ON SECOND OPERATION, ALL OF THE CERAMENT WITHIN THE CAVITY WAS LIQUID - NOT SOLID. RETURN TO OPERATING ROOM TO REMOVE CERAMENT AND RE-CLOSE THE INCISION. UNNECESSARY ANESTHESIA, COST OF RE-OPERATION. ENTEROBACTER CLOACAE COMPLEX INFECTION DUE TO OPEN WOUND REQUIRING INFECTIOUS DISEASE CONSULT, IV FOLLOWED BY LONG TERM PO ANTIBIOTICS. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.
POST-OPERATIVELY THE INCISION HEALED NICELY THEN WEEKS LATER THE INCISION OPENED AND STARTED DRAINING LIQUID CERAMENT. ON SECOND OPERATION, ALL OF THE CERAMENT WITHIN THE CAVITY WAS LIQUID - NOT SOLID. RETURN TO OPERATING ROOM TO REMOVE CERAMENT AND RE-CLOSE THE INCISION. UNNECESSARY ANESTHESIA, COST OF RE-OPERATION. ENTEROBACTER CLOACAE COMPLEX INFECTION DUE TO OPEN WOUND REQUIRING INFECTIOUS DISEASE CONSULT, IV FOLLOWED BY LONG TERM PO ANTIBIOTICS. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.
POST-OPERATIVELY THE INCISION HEALED NICELY THEN WEEKS LATER THE INCISION OPENED AND STARTED DRAINING LIQUID CERAMENT. ON SECOND OPERATION, ALL OF THE CERAMENT WITHIN THE CAVITY WAS LIQUID - NOT SOLID. RETURN TO OPERATING ROOM TO REMOVE CERAMENT AND RE-CLOSE THE INCISION. UNNECESSARY ANESTHESIA, COST OF RE-OPERATION. ENTEROBACTER CLOACAE COMPLEX INFECTION DUE TO OPEN WOUND REQUIRING INFECTIOUS DISEASE CONSULT, IV FOLLOWED BY LONG TERM PO ANTIBIOTICS. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2127468 | CERAMENT BONE VOID FILLER | CERAMENT BONE VOID FILLER | MQV | BONESUPPORT AB | A0210-08 | MLOT0983 | 07350055430035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Female | Hospitalization| R |