GRANULES FOR FILLING - STERILE PRODUCTS
Report
- Report Number
- 3004549189-2025-00007
- Event Type
- Malfunction
- Date Received
- April 7, 2025
- Date of Event
- March 17, 2025
- Report Date
- June 13, 2025
- Manufacturer
- S.B.M. SAS
- Product Code
- MQV
- PMA / PMN Number
- K021963
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
APRIL 02, 2025. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. ADDITIONAL INFORMATION REQUESTED ON MARCH 20, 2025: - WHAT WAS THE DATE OF THE INCIDENT? - HAVE THE PRODUCTS BEEN USED? - IF NOT, WHAT WAS USED TO COMPLETE THE PROCEDURE? - IS THERE AN IMPACT TO PATIENT? - EVENT RELATED INCREASE IN SURGICAL TIME OF MORE THAN 30 MINUTES? - DO YOU HAVE ANY PHOTOS OF THE PRODUCT? INCIDENT REPORT RECEIVED ON MARCH 27, 2025: NO CLINICAL CONSEQUENCES TO THE PATIENT AND NO DELAY IN SURGERY OVER THAN 30MN. DATE OF THE INCIDENT: MONTH AND YEAR INFORMATION ONLY (DAY NOT SPECIFIED). RESULT OF ANALYSIS: THESE PRODUCTS HAVE A QUANTITY ERROR IN THE VIALS: LESS GRANULES THAN SPECIFIED IN THE PACKAGING REFERENTIAL. THIS QUANTITY ERROR CAN GENERATE A POTENTIAL DELAY DURING SURGERY IF THE SURGEON RUNS OUT OF GRANULES. 1 PRODUCTION OF 30 DEVICES IS CONCERNED. 1 CUSTOMER COMPLAINT WAS REGISTERED. 10 PRODUCTS DELIVERED IN THE USA TO A DISTRIBUTOR / DEVICES NOT USED. INCORRECT QUANTITY OF GRANULES RESULTING IN INSUFFICIENT IMPLANTABLE DEVICES AVAILABLE. POSSIBLE CONSEQUENCE: PROLONGED OPERATING TIME FOR THE SURGEON TO PROCURE REPLACEMENT DEVICES. NO OR INSUFFICIENT BONE VOID FILLING. POTENTIAL IMPACT ON THE PATIENT: POOR CONSOLIDATION IF NO DEVICE IS IMPLANTED, OR IF INSUFFICIENT DEVICES ARE IMPLANTED. DELAYED FUSION / PSEUDARTHROSIS. THIS BATCH IS BEING RECALLED TO AVOID ANY IMPACT ON THE PATIENT IF THE LACK OF GRANULES CAUSES A POSSIBLE DELAY IN SURGERY OR INSUFFICIENT FILLING OF THE BONE VOID. MAY 13, 2025 - FOLLOW-UP1: ADDED TRANSLATION OF INCIDENT DESCRIPTION INTO ENGLISH (B5 SECTION). JUNE 16, 2025 - FOLLOW UP2: FINAL REPORT_CLOSURE OF FIELD ACTION. SBM HAS CONDUCTED A FIELD ACTION FROM THE LOT 240781 AND IDENTIFIED 10 PRODUCTS DELIVERED TO 1 DISTRIBUTOR IN USA. THE 10 DEVICES WERE DESTROYED BY THE DISTRIBUTOR. CORRECTIVE ACTION: MASS CONTROL / CREATION OF A PACKAGING CONTROL SHEET FOR GRANULES (BIO1 PRODUCT FAMILY) WITH THE WEIGHT OF THE 1ST VIAL(S) ACCORDING TO THE REFERENCE. DOCUMENT REFERENCE: (B)(4). NEW RISK ADDED TO OUR RISK ANALYSIS DOCUMENT (B)(4) NON-CONFORMING QUANTITY PACKAGED RESULTING IN INSUFFICIENT QUANTITY OF IMPLANTABLE DEVICES AVAILABLE. THIS FSCA IS CONSIDERED CLOSED PER SBM PROCESS.
APRIL 02, 2025. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. ADDITIONAL INFORMATION REQUESTED ON MARCH 20, 2025: - WHAT WAS THE DATE OF THE INCIDENT? - HAVE THE PRODUCTS BEEN USED? - IF NOT, WHAT WAS USED TO COMPLETE THE PROCEDURE? - IS THERE AN IMPACT TO PATIENT? - EVENT RELATED INCREASE IN SURGICAL TIME OF MORE THAN 30 MINUTES? - DO YOU HAVE ANY PHOTOS OF THE PRODUCT? INCIDENT REPORT RECEIVED ON MARCH 27, 2025: NO CLINICAL CONSEQUENCES TO THE PATIENT AND NO DELAY IN SURGERY OVER THAN 30MN. DATE OF THE INCIDENT: MONTH AND YEAR INFORMATION ONLY (DAY NOT SPECIFIED). RESULT OF ANALYSIS: THESE PRODUCTS HAVE A QUANTITY ERROR IN THE VIALS: LESS GRANULES THAN SPECIFIED IN THE PACKAGING REFERENTIAL. THIS QUANTITY ERROR CAN GENERATE A POTENTIAL DELAY DURING SURGERY IF THE SURGEON RUNS OUT OF GRANULES. 1 PRODUCTION OF 30 DEVICES IS CONCERNED. 1 CUSTOMER COMPLAINT WAS REGISTERED. 10 PRODUCTS DELIVERED IN THE USA TO A DISTRIBUTOR / DEVICES NOT USED. INCORRECT QUANTITY OF GRANULES RESULTING IN INSUFFICIENT IMPLANTABLE DEVICES AVAILABLE. POSSIBLE CONSEQUENCE: PROLONGED OPERATING TIME FOR THE SURGEON TO PROCURE REPLACEMENT DEVICES. NO OR INSUFFICIENT BONE VOID FILLING. POTENTIAL IMPACT ON THE PATIENT: POOR CONSOLIDATION IF NO DEVICE IS IMPLANTED, OR IF INSUFFICIENT DEVICES ARE IMPLANTED. DELAYED FUSION / PSEUDARTHROSIS. THIS BATCH IS BEING RECALLED TO AVOID ANY IMPACT ON THE PATIENT IF THE LACK OF GRANULES CAUSES A POSSIBLE DELAY IN SURGERY OR INSUFFICIENT FILLING OF THE BONE VOID. MAY 13, 2025 - FOLLOW-UP1. ADDED TRANSLATION OF INCIDENT DESCRIPTION INTO ENGLISH (B5 SECTION).
APRIL 02, 2025 NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. ADDITIONAL INFORMATION REQUESTED ON MARCH 20, 2025: - WHAT WAS THE DATE OF THE INCIDENT? - HAVE THE PRODUCTS BEEN USED? - IF NOT, WHAT WAS USED TO COMPLETE THE PROCEDURE? - IS THERE AN IMPACT TO PATIENT? - EVENT RELATED INCREASE IN SURGICAL TIME OF MORE THAN 30 MINUTES? - DO YOU HAVE ANY PHOTOS OF THE PRODUCT? INCIDENT REPORT RECEIVED ON MARCH 27, 2025: NO CLINICAL CONSEQUENCES TO THE PATIENT AND NO DELAY IN SURGERY OVER THAN 30MN. DATE OF THE INCIDENT: MONTH AND YEAR INFORMATION ONLY (DAY NOT SPECIFIED). RESULT OF ANALYSIS: THESE PRODUCTS HAVE A QUANTITY ERROR IN THE VIALS: LESS GRANULES THAN SPECIFIED IN THE PACKAGING REFERENTIAL. THIS QUANTITY ERROR CAN GENERATE A POTENTIAL DELAY DURING SURGERY IF THE SURGEON RUNS OUT OF GRANULES. 1 PRODUCTION OF 30 DEVICES IS CONCERNED. 1 CUSTOMER COMPLAINT WAS REGISTERED. 10 PRODUCTS DELIVERED IN THE USA TO A DISTRIBUTOR / DEVICES NOT USED. INCORRECT QUANTITY OF GRANULES RESULTING IN INSUFFICIENT IMPLANTABLE DEVICES AVAILABLE. POSSIBLE CONSEQUENCE: PROLONGED OPERATING TIME FOR THE SURGEON TO PROCURE REPLACEMENT DEVICES. NO OR INSUFFICIENT BONE VOID FILLING. POTENTIAL IMPACT ON THE PATIENT: POOR CONSOLIDATION IF NO DEVICE IS IMPLANTED, OR IF INSUFFICIENT DEVICES ARE IMPLANTED. DELAYED FUSION / PSEUDARTHROSIS. THIS BATCH IS BEING RECALLED AVOIDING ANY IMPACT ON THE PATIENT IF THE LACK OF GRANULES CAUSES A POSSIBLE DELAY IN SURGERY OR INSUFFICIENT FILLING OF THE BONE VOID.
(B)(4). INCIDENT OCCURED IN ITALY. TRADUCTION: NON-CONFORMITY FOUND ON MD REF (B)(4) MICROGRANULES OF BONE SUBSTITUTE OF SYNTHETIC ORIGIN (REPERTORY N 14417, CND P900401) LOT 240781 EXP 01/03/2029: WHEN THE PACKAGE IS OPENED, THE VIAL IS ONLY MINIMALLY FILLED INSIDE WITH SUCH A QUANTITY OF MICROGRANULES THAT IS NOT SUFFICIENT FOR THE PROPER USE OF THE DEVICE.THE SAME ISSUE WAS FOUND ON 5 VIALS BELONGING TO THE SAME LOT (2 OF WHICH ARE AVAILABLE AT THE OPERATING BLOCK PHARMACY). THE REINSTATEMENT OF THE BOTTLES OR THE ISSUANCE OF A CREDIT NOTE IS REQUESTED.
(B)(4). INCIDENT OCCURED IN ITALY. TRADUCTION: NON-CONFORMITY FOUND ON MD REF (B)(4) MICROGRANULES OF BONE SUBSTITUTE OF SYNTHETIC ORIGIN (REPERTORY N 14417, CND P900401) LOT 240781 EXP 01/03/2029: WHEN THE PACKAGE IS OPENED, THE VIAL IS ONLY MINIMALLY FILLED INSIDE WITH SUCH A QUANTITY OF MICROGRANULES THAT IS NOT SUFFICIENT FOR THE PROPER USE OF THE DEVICE.THE SAME ISSUE WAS FOUND ON 5 VIALS BELONGING TO THE SAME LOT (2 OF WHICH ARE AVAILABLE AT THE OPERATING BLOCK PHARMACY). THE REINSTATEMENT OF THE BOTTLES OR THE ISSUANCE OF A CREDIT NOTE IS REQUESTED.
(B)(4). INCIDENT OCCURED IN ITALY. TRADUCTION: NON-CONFORMITY FOUND ON MD REF (B)(4) MICROGRANULES OF BONE SUBSTITUTE OF SYNTHETIC ORIGIN (REPERTORY N 14417, CND P900401) LOT 240781 EXP 01/03/2029: WHEN THE PACKAGE IS OPENED, THE VIAL IS ONLY MINIMALLY FILLED INSIDE WITH SUCH A QUANTITY OF MICROGRANULES THAT IS NOT SUFFICIENT FOR THE PROPER USE OF THE DEVICE. THE SAME ISSUE WAS FOUND ON 5 VIALS BELONGING TO THE SAME LOT (2 OF WHICH ARE AVAILABLE AT THE OPERATING BLOCK PHARMACY). THE REINSTATEMENT OF THE BOTTLES OR THE ISSUANCE OF A CREDIT NOTE IS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654215 | GRANULES FOR FILLING - STERILE PRODUCTS | BIO 1® GRANULES FOR FILLING Ø 1 MM (2 CM³) | MQV | S.B.M. SAS | 240781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Unknown | Other |