MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 15CC STANDARD MORSEL VIAL; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE.

Catalog Number	2102-0010
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "an expired cement (expiry date = (b)(6) 2016) was implanted into a patient during a procedure." the surgeon wants to confirm if there is any potential risk for the patient.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: device history review indicated all devices accepted into final stock met specifications.Device evaluation could not be performed as no items were returned.Complaint history review indicated there have been no other similar complaints for this reported lot.Conclusion: the probable root cause is user error.
Event or Problem Description
It was reported that "an expired cement (expiry date = 30/09/2016) was implanted into a patient during a procedure." the surgeon wants to confirm if there is any potential risk for the patient.

• Brand Name: 15CC STANDARD MORSEL VIAL
• Common Device Name: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE.
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 6170149
• Report Number: 0002530131-2016-00019
• Device Sequence Number: 967360
• Product Code: MQV
• UDI-Device Identifier: 00808232000122
• UDI-Public: (01)00808232000122
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 2102-0010
• Device Lot Number: A1309024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1