MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS BBTRAUMA FOAM PACK 5CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Model Number	2102-2205
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Codes	Failure of Implant (1924); Swelling (2091); Injury (2348)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; as reported by rep: surgeon notified via sms that post implant for a procedure, foot became swollen.Upon re-opening the wound, surgeon reported that the product "looks like it puffed up after pulse lavage".A screw [exact screw unknown] in the plate was found loose and explanted.Rep reported that patient sustained vocal chord damage after intubation and was administered prednazone.As of the time of report, patient had not gotten their voice back.Patient has retained a lawyer.
Additional Manufacturer Narrative
Method: device history review, complaint history review; risk assessment; result: device evaluation could not be performed as the device was not returned.Device history review indicated all devices accepted into final stock met specifications.No discrepancies occurred during the manufacturing of this lot.Complaint history review indicated there have been no other similar complaints for this reported lot.The root cause cannot be identified and the failure cannot be confirmed.
Event or Problem Description
It was reported that; as reported by rep: surgeon notified via sms that post implant for a procedure, foot became swollen.Upon re-opening the wound, surgeon reported that the product "looks like it puffed up after pulse lavage".A screw [exact screw unknown] in the plate was found loose and explanted.Rep reported that patient sustained vocal chord damage after intubation and was administered prednazone.As of the time of report, patient had not gotten their voice back.Patient has retained a lawyer.

• Brand Name: VITOSS BBTRAUMA FOAM PACK 5CC
• 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: 7112474
• Report Number: 0002530131-2017-00013
• Device Sequence Number: 13790987
• Product Code: MQV
• UDI-Device Identifier: 00808232001334
• UDI-Public: (01)00808232001334
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: 2102-2205
• Device Catalogue Number: 2102-2205
• Device Lot Number: B1704008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/09/2018
• 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