MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS FOAM PACK 1.2CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Model Number	2102-1401
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Codes	Fatigue (1849); Reaction (2414)
Date of Event	09/10/2015
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient came in for follow-up.Unspecific symptoms and local throat soft tissue turgor, abnormal fatigue and listlessness in timely connection with the cervical spine surgery.For a differential diagnostic a potential allergy reaction on the implant could be possible.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified as all released units met specifications.Visual, functional and dimensional inspection were not performed because items were not returned.Conclusion: the alleged unspecific symptoms reported cannot be confirmed 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 came in for follow-up.Unspecific symptoms and local throat soft tissue turgor, abnormal fatigue and listlessness in timely connection with the cervical spine surgery.For a differential diagnostic a potential allergy reaction on the implant could be possible.

• Brand Name: VITOSS FOAM PACK 1.2CC
• 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: 6827776
• Report Number: 0002530131-2017-00011
• Device Sequence Number: 712231
• Product Code: MQV
• UDI-Device Identifier: 00808232000412
• UDI-Public: (01)00808232000412
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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: 02/28/2017
• Device Model Number: 2102-1401
• Device Catalogue Number: 2102-1401
• Device Lot Number: B1502010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR