CERAMENT BONE VOID FILLER
Report
- Report Number
- 3005304945-2024-00002
- Event Type
- Injury
- Date Received
- April 26, 2024
- Date of Event
- January 14, 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
MLOT1151 (A0210-08, CERAMENT BONE VOID FILLER), MANUFACTURING DATE: 09/14/2023, EXPIRATION DATE: 02/09/2027. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT1151 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN 10/04/2023, 482 DEVICES OF THE TOTAL BATCH SIZE OF 629 DEVICES HAVE BEEN SOLD. NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE BATCH. 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 MEDICAL INVESTIGATION: THE INFORMATION TO THIS COMPLAINT IS SUFFICIENT TO DRAW SOME CONCLUSIONS. "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, BUT THE WOUND WAS INFECTED, AND REOPERATION WAS NEEDED. THE WOUND HEALED AND THE PATIENT IS NOW DOING WELL. THE PRODUCT WAS USED IN A REASONABLE WAY. THE PATIENT HAD COMPLICATIONS WHICH RESULTED IN A REOPERATION, AND ALTHOUGH THE INCIDENT IS CONSIDERED AS EXPECTED AND FORESEEABLE EVENT WHICH IS DESCRIBED IN THE RISK ASSESSMENT AND THE INSTRUCTIONS FOR USE FOR CERAMENT BONE VOID FILLER. IT WAS DECIDED TO PERFORM SOME FURTHER INVESTIGATIONS AT BONESUPPORT, THEREFORE A SAFETY RELATED CAPA (CAPA-0166) WAS INITIATED. 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.
THE ROOT-CAUSE INVESTIGATION CONCLUDED THAT THE PRODUCT HAS NOT MALFUNCTIONED AND NOT FOLLOWING THE PRECAUTION DEFINED IN THE INSTRUCTION FOR USE, IFU-0007-12 SEEMS TO BE THE MOST LIKELY CAUSE FOR WHITE-DRAINAGE AND THEREBY RE-OPERATION IN THIS CASE. THERE IS A PRECAUTION IN THE IFU007-12 STATING: "IN ANEURYSMAL BONE CYSTS (ABCS) AND OTHER BONE CYSTS PRONE TO PRODUCING LARGE VOLUMES OF FLUID, THERE IS INCREASED RISK OF WOUND DRAINAGE, SOFT-TISSUE INFLAMMATION AND WOUND BREAKDOWN IF TREATED BY OPEN SURGERY. USE CERAMENT BONE VOID FILLER IN BEAD FORM RATHER THAN COMPLETE VOID FILLING FOR THESE INDICATIONS." AND EVEN THOUGH WHITE DRAINAGE IS A WELL-KNOWN OCCURRENCE IN CALCIUM-BASED BONE VOID FILLERS. THE USE OF CERAMENT BONE VOID FILLER IN BEAD FORM MIGHT HAVE LED TO A LESS SEVERE COMPLICATION.
MLOT1151 (A0210-08, CERAMENT BONE VOID FILLER), MANUFACTURING DATE: 09/14/2023, EXPIRATION DATE: 02/09/2027. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT1151 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN (B)(6) 2023, (B)(4). NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE BATCH. 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 MEDICAL INVESTIGATION: THE INFORMATION TO THIS COMPLAINT IS SUFFICIENT TO DRAW SOME CONCLUSIONS. "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, BUT THE WOUND WAS INFECTED, AND REOPERATION WAS NEEDED. THE WOUND HEALED AND THE PATIENT IS NOW DOING WELL. THE PRODUCT WAS USED IN A REASONABLE WAY. THE PATIENT HAD COMPLICATIONS WHICH RESULTED IN A REOPERATION, AND ALTHOUGH THE INCIDENT IS CONSIDERED AS EXPECTED AND FORESEEABLE EVENT WHICH IS DESCRIBED IN THE RISK ASSESSMENT AND THE INSTRUCTIONS FOR USE FOR CERAMENT BONE VOID FILLER. IT WAS DECIDED TO PERFORM SOME FURTHER INVESTIGATIONS AT BONESUPPORT, THEREFORE A SAFETY RELATED CAPA (CAPA-0166) WAS INITIATED. SEE ATTACHMENT FOR COMPLETE MEDICAL INVESTIGATION REPORT.
MLOT1151 (A0210-08, CERAMENT BONE VOID FILLER), MANUFACTURING DATE: 09/14/2023, EXPIRATION DATE: 02/09/2027. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT1151 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN (B)(6) 2023, (B)(4) DEVICES OF THE TOTAL BATCH SIZE OF (B)(4) DEVICES HAVE BEEN SOLD. NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE BATCH. THE MEDICAL INVESTIGATION OF THE COMPLAINT WILL BE SUBMITTED IN A FOLLOW-UP REPORT AFTER RECEIVING ADDITIONAL DATA FROM THE RESPONSIBLE PHYSICIAN.
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. INFECTION (MRSA) DUE TO OPEN WOUND REQUIRING LONG TERM 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. INFECTION (MRSA) DUE TO OPEN WOUND REQUIRING LONG TERM 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. INFECTION (MRSA) DUE TO OPEN WOUND REQUIRING LONG TERM ANTIBIOTICS. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2126483 | CERAMENT BONE VOID FILLER | CERAMENT BONE VOID FILLER | MQV | BONESUPPORT AB | A0210-08 | MLOT1151 | 07350055430035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female | Required Intervention| H |