[3323707]
On (b)(6) 2013, a spontaneous report was received by a company representative from an oral surgery assistant involving equimatrix. An initial request to return the product was received by customer service because the dental provider was dissatisfied with the outcome of the product. In follow up, the oral surgery assistant stated that the dental provider was not happy with the results and that the product was ineffective. The reporter stated that it involved a few patients over a period of time and was not a specific lot or product code but the product in general. On (b)(6) 2013, additional information was received by facsimile from the oral surgery assistant forwarded from the dental provider involving a total of 7 patients. This case involved patient #(b)(6), a (b)(6) female who was a non-smoker. Additional medical history and concomitant medication use were not provided. Tooth number 30 area had previously been extracted. No infection was noted and the area was grafted with equimatrix (lot number unknown) on (b)(6) 2012. Good closure was achieved. Post procedure medications included tylenol #3 and amoxicillin (dose, route frequency not reported). On (b)(6) 2013, a radiograph was taken and resorption was noted. The patient was currently waiting for another bone graft. On (b)(6) 2013 additional information was received by a company dental consultant with information from the dental provider and included the following: the patient is a (b)(6) female non-smoker. On (b)(6) 2012 an 8. 5 mm platform-switched nobel active bio-care (co-suspect), wide platform implant was placed into tooth #30 site. Equimatrix alone (quantity unknown); autogenous bone scrapings (co-suspect) and bio-mend membrane (co-suspect) graft materials were placed adjacent to the buccal coronal aspect of the implant platform. On (b)(6) 2012 a periapical dental radiograph was taken which showed loss of crestal bone and no evidence of the prior equimatrix graft. The patient is scheduled to be regrafted at some unknown future date. On (b)(6) 2013, additional information was received by a company dental consultant with information from the dental provider and included the following: of note, with the information received on (b)(6) 2013, this case was upgraded to medically serious. The dental provider reopened and regrafted the area adjacent to the implant placed on (b)(6) 2012. An image was provided which was just prior to debridement. The dental provider stated that the area opened. Soft tissue and unincorporated graft material were noted around the implant. No pus or other sign of infection. Another image was provided that was taken after debridement, with the following quote from the dental provider. "after debridement, no graft remained. There is less bone around the implant then prior to grafting. " the provider regrafted the area of coronal bone loss with a composite graft of bio-oss plus gem 21s and covered the area with a membrane. Note: luitpold pharmaceuticals considered the following products co-suspect in the reported reactions: autogenous bone scrappings, bio-mend and nobel implant. Due to technical limitations of the database in accommodating four co-suspect products. The co-suspect product autogenous bone scrappings could not be entered into the database under co-suspect products. This case has been linked to 2013-0054, 2013-0065, 2013-0068, 2013-0069, 2013-0071, 2013-0072, 2013-0075, 2013-0077, 2013-0078, 2013-0130, 2013-0131, 2013-0136, 2013-0139, 2013-0140 and product quality case 2013-0053.
Patient Sequence No: 1, Text Type: D, B5