MAUDE Adverse Event Report: BONESUPPORT AB CERAMENT BONE VOID FILLER; CALCIUM SALT BONE VOID FILLER

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Impaired Healing (2378)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

Patient with tibial plateau fracture treated with osteosynthesis and cerament bvf.Continuing pain after 2 years.Ct scans after six, eighteen and 24 months show progressively empty void.The patient is re-operated with re-osteosynthesis and autograft.Ct scan six months post-operatively showed piece of joint surface displaced and direct contact between joint and cerament bvf.Conclusion is that cerament bvf was resorbed due to unintentional direct contact between cerament bvf and joint fluid.The risk analysis will be updated with this risk.

Event Description

Patient with tibial plateau fracture initially treated with osteosyntheses and cerament bone void filler complains of pain at physiotherapy a few weeks after surgery.Ct scans were done after six months and two years and show that a part of the joint surface is displaced and that the cerament bone void filler in an area posteriorly is in direct contact with the joint and after two years the void was observed to be empty.Revision surgery was carried out with reosteosynthesis and autograft.

• Brand Name: CERAMENT BONE VOID FILLER
• Type of Device: CALCIUM SALT BONE VOID FILLER
• Manufacturer (Section D): BONESUPPORT AB; scheelevägen 19; ideon science park; lund, skane SE-22 3 70; SW SE-223 70
• Manufacturer (Section G): BONESUPPORT AB; scheelvagen 19; ideon science park; lund, skane SE-22 3 70; SW SE-223 70
• Manufacturer Contact: gabriella gaerds ; scheelevägen 19; ideon science park; lund, skane SE-22-3 70 ; SW SE-223 70 ; 46 2865358
• MDR Report Key: 6269478
• MDR Text Key: 65505360
• Report Number: 3005304945-2016-00004
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: K073316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: A0210-10
• Device Lot Number: MLOT0148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR