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

Catalog Number 2102-1405

Device Problems Biocompatibility (2886); Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 05/20/2016

Event Type  Injury  

Event 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.

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 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
• Type of Device: VITOSS FOAM
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5920586
• MDR Text Key: 53679244
• Report Number: 0002530131-2016-00013
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 04546540149220
• UDI-Public: (01)04546540149220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2102-1405
• Device Lot Number: B1306005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2013
• 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): Other
• Patient Age: 63 YR