Description of Event or Problem · 1
ON (B)(6) 2010, STRYKER PVG LEARNED OF AN ADVERSE EVENT IN THE LITERATURE: BIRKE ET AL, 'PRELIMINARY EXPERIENCE WITH THE COMBINED USE OF RECOMBINANT BONE MORPHOGENETIC PROTEIN AND BISPHOSPHONATES IN THE TREATMENT OF CONGENITAL PSEUDARTHROSIS OF THE TIBIA', PUBLISHED IN J CHILD ORTHOP (2010) 4, 507-517. IN THE ARTICLE, THE AUTHORS REPORT THAT A (B)(6) MALE PT WITH NEUROFIBROMATOSIS TYPE 1 (NF1) DEVELOPED A 'PIN TRACK' INFECTION AFTER RECEIVING OP-1 FOR PSEUDARTHROSIS OF THE TIBIA. THE AUTHORS REPORT THAT THE INFECTION WAS SUCCESSFULLY TREATED WITH ORAL ANTIBIOTICS (NOS). ADDITIONAL INFO WAS REQUESTED FROM THE AUTHORS ON 12/08/2010 AND 12/15/2010. ON (B)(6) 2010, THE CORRESPONDING AUTHOR NOTIFIED STRYKER PVG VIA EMAIL THAT HE WOULD BE UNABLE TO PROVIDE ADDITIONAL INFO REGARDING THE PTS IN THE ARTICLE. NO FURTHER INFO IS EXPECTED.