MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS FOAM PACK 5CC

Catalog Number	2102-1405
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Reaction (2414)
Date of Event	05/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient received a posterior lumbar decompression infusion at l4-l5 in (b)(6) 2014.She recently started to experience a lot of aching and pain and her surgeon suggests this may be an allergic reaction to the implant.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assesment; result: device history review indicated all devices released 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 events for this reported lot.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and/or insufficient information was provided for review.Per the ifu; "when hypersensitivity is suspected or proven, it is recommended that the tolerance of the skin to the materials that make up the implants be checked before they are implanted" and "pain, discomfort, or abnormal sensations due to the presence of the device" are known adverse effects and removal may also be recommended in "pain or abnormal sensations due to the presence of the implants.Infection or inflammatory reactions".Conclusion: the exact root cause could not be determined because the devices were not returned for evaluation and/or insufficient information was provided for review.
Event or Problem Description
It was reported that; patient received a posterior lumbar decompression infusion at l4-l5 in (b)(6) 2014.She recently started to experience a lot of aching and pain and her surgeon suggests this may be an allergic reaction to the implant.

• Brand Name: VITOSS FOAM PACK 5CC
• Common Device Name: VITOSS FOAM
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5920586
• Report Number: 0002530131-2016-00013
• Device Sequence Number: 13583555
• Product Code: MQV
• UDI-Device Identifier: 04546540149220
• UDI-Public: (01)04546540149220
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2016

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 Catalogue Number: 2102-1405
• Device Lot Number: B1306005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Supplement Report FDA Received Date: 10/17/2016
• 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: Other
• Patient Age: 63 YR