CERAMENT BONE VOID FILLER
Report
- Report Number
- 3005304945-2024-00004
- Event Type
- Injury
- Date Received
- April 26, 2024
- Date of Event
- February 29, 2024
- Report Date
- March 29, 2024
- Manufacturer
- CERAMENT BONE VOID FILLER
- Product Code
- MQV
- UDI-DI
- 07350055430066
- PMA / PMN Number
- K201535
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MLOT1127 (A0210-11, CERAMENT BONE VOID FILLER), MANUFACTURING DATE: 06/29/2023, EXPIRATION DATE: 24/03/2026. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT1127 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN 08/07/2023, 379 DEVICES OF THE TOTAL BATCH SIZE OF 531 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. THE FOLLOWING INFORMATION WAS ADDED 20TH JUNE 2024: ADDITIONAL INFORMATION WAS RECEIVED ON THE 24TH APRIL 2024 FROM THE SURGEON. THE INFORMATION TO THIS COMPLAINT IS SUFFICIENT TO DRAW SEVERAL 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 INSTRUCTIONS FOR USE AND IN THE RISK ASSESSMENT FOR CERAMENT BONE VOID FILLER. THE SURGEON ALSO INFORMED US THAT CULTURES WERE NEGATIVE AND PATIENT IS NOW HEALING WELL. THE PRODUCT WAS USED IN A REASONABLE WAY. THE PATIENT HAD COMPLICATIONS WHICH RESULTED IN A RE-OPERATION, 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. THE FOLLOWING INFORMATION WAS ADDED ON THE 10TH OF JULY 2024: INVESTIGATIONS ARE STILL ONGOING AT BONESUPPORT, WITHIN CAPA-0166 AS REFERRED ABOVE.
THE ROOT-CAUSE INVESTIGATION CONCLUDED THAT THERE IS NO CLEAR CAUSE OTHER THAN BEING AN EXPECTED UNDESIRABLE SIDE EFFECT. "WHITE DRAINAGE" IS A WELL-KNOWN OCCURRENCE IN CALCIUM-BASED BONE VOID FILLERS. THE INCIDENT CONSIDERED IS AN EXPECTED AND FORESEEABLE EFFECT WHICH IS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU0007-12) AND IN THE RISK ASSESSMENT FOR CERAMENT BONE VOID FILLER.
MLOT1127 (A0210-11, CERAMENT BONE VOID FILLER), MANUFACTURING DATE: 06/29/2023, EXPIRATION DATE: 24/03/2026. MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT1127 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.
MLOT1127 (A0210-11, CERAMENT BONE VOID FILLER), MANUFACTURING DATE: 06/29/2023, EXPIRATION DATE: 24/03/2026 MANUFACTURER BATCH INVESTIGATION: REVIEW OF BATCH RECORDS FOR MLOT1127 INCLUDING QUALITY RELEASE RESULTS HAS BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS. THE FIRST DEVICE FROM THE BATCH WAS SOLD IN 08/07/2023, (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 RECIEVING ADDITIONAL DATA FROM THE RESPONSIBLE PHYSICIAN. THE FOLLOWING INFORMATION WAS ADDED 20TH JUNE 2024: ADDITIONAL INFORMATION WAS RECEIVED ON THE 24TH APRIL 2024 FROM THE SURGEON. THE INFORMATION TO THIS COMPLAINT IS SUFFICIENT TO DRAW SEVERAL 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 INSTRUCTIONS FOR USE AND IN THE RISK ASSESSMENT FOR CERAMENT BONE VOID FILLER. THE SURGEON ALSO INFORMED US THAT CULTURES WERE NEGATIVE AND PATIENT IS NOW HEALING WELL. THE PRODUCT WAS USED IN A REASONABLE WAY. THE PATIENT HAD COMPLICATIONS WHICH RESULTED IN A RE-OPERATION, 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.
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. 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. 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. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2308076 | CERAMENT BONE VOID FILLER | CERAMENT BONE VOID FILLER | MQV | CERAMENT BONE VOID FILLER | A0210-11 | MLOT1127 | 07350055430066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Female | Hospitalization| R |