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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned and no additional information could be obtained.The leakage to soft tissue and subsequent inflammation, swelling and drainage was thought to be caused by insufficient wound closure and/or uncontained void and/or early load-bearing.
Event or Problem Description
It was reported that patient had a benign tumor removed from the distal tibia.The 54 ml cerament were used to fill the bone void.Almost 2 months after surgery the patient presented at the hospital with a painful swelling of the lower leg.Hospital stated that the cerament "leaked" out of the void and into the soft tissue.Cerament was removed, bone void debrided and filled with palacos bone cement with gentamicin.No infection was noted by the surgeon and no cultures were taken.The above is based on information received from the distributor.

• Brand Name: CERAMENT BONE VOID FILLER
• Common Device Name: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): BONESUPPORT AB; scheelevägen 19; lund, skåne SE-22 370; SW SE-22370
• MDR Report Key: 6940186
• Report Number: 3005304945-2017-00005
• Device Sequence Number: 1070106
• Product Code: MQV
• Combination Product (Y/N): N
• PMA/510(K) Number: K073316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: N/A
• Device Catalogue Number: A0210-11
• Device Lot Number: MLOT0211 AND MLOT0277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2016
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention