|
On (b)(6) 2015, an initial, spontaneous report was received by (b)(4) from a dentist via an email from a sales representative concerning first of three patients (patient identifiers not provided) who was administered equimatrix cancellous (no product information provided) and the bone dissolved 1 week after grafting with equimatrix (meddra: graft loss).No further information was provided.On (b)(6) 2015, additional information was received from the dentist via telephone contact from a company representative.This report is referenced as case # 1 (first of eight) which involved tooth #11, maxillary left canine was removed.The tooth was in labial version and had an intact but thin labial wall.Following removal a 3.2 mm x 16 mm immediate implant was placed toward the palatal aspect of the socket.Equimatrix was grafted into the gap between the implant body and the inner socket walls.For 1.5 months following tooth extraction, implant placement and grafting the patient experienced significant pain (meddra: pain).At 1.5 months post-surgery, the implant was clearly mobile and was removed (meddra:device failure).Copious amounts of inflammatory, granulomatous tissue was removed from the site (meddra: soft tissue inflammation and excessive granulation tissue).No sign of purulent drainage was evident.A large palatal defect was observed (meddra: palatal disorder).According to the dentist, both the palatal and labial of bone were resorbed (meddra: bone loss).No further information provided.On 28oct2015, additional information was received from the dentist via an email from a company representative.The implant was removed after 5 weeks of pain and embarrassment (not further specified) and was grafted with mfdba and the pain has now subsided.On 14nov2015, additional information was received via email from the dentist who reported that 5 months post-op while taking an impression it was discovered there was irritated gingival on df line angle of screw retained temp crown from first week of post-op.The gp from the mf sulcus went all the way 20 to the base of 16 mm implant.The lesion has dissolved the palatal bone and also communicating with incisive canal.The dentist considers the equimatrix as the cause of the events the patient experienced.Upon medical review the following events were considered serious (required intervention): significant pain, implant clearly mobile and removed, large palatal defect and palatal and labial plates of bone resorbed.No further information provided.Company assessment: increased implant and graft failure rates can be expected in patients exhibiting risk factors such as systemic diseases, smokers, chronic periodontitis, and periapical pathology.In addition, certain anatomic factors including thin tissue biotype, buccal wall defects, and poor bone density are important determinants of risk assessment.The following comments apply to all equimatrix cases reported by the dentist.The causality assessment of all cases is hampered due to a lack of detailed information: no patient identifiers were furnished.No patient demographic information, social history, or habit history was provided no information regarding patients' medical history, past dental history, medications or current medical status that might influence normal wound healing was provided no clinical or radiographic diagnosis (except as noted in individual reports) no description of details of treatment rendered no specification of concomitant medical devices used during surgery (except as noted) such as other graft materials, implant type, membranes, etc.No details of the surgical procedures were provided and there was no information about how graft materials were protected during healing.No comments on occlusal analysis or occlusal status and parafunctional habits was provided radiographs were not provided for the majority of cases.When provided, they were not labeled or dated (except as noted).Cbct images provided were screen shots that were not labeled and in some cases not dated.Pre- and post-surgery cbct images were from different sections and could not be compared.Radiographic and cbct images did not coincide with description provided by the dentist in the accompanying e-mails.Tooth number and implant sites were not specified for cases and sites with complications were not always identified.Based on company representative's telephone conversation with the dentist on (b)(6) 2015, no flaps were reflected prior to initiating any surgery potentially limiting a thorough direct clinical examination following tooth removal as well as possibly compromising a thorough postextraction debridement of each treated site.According to the package insert, "in order to assure the formation of new bone, equimatrix should only be placed in direct contact with well vascularized bone.Cortical bone should be mechanically perforated, if necessary." without reflecting a flap, it would be impossible to determine whether the equimatrix was being placed in direct contact with well-vascularized bone, especially if significant socket wall defects were present without reflecting a flap, it would be difficult, at best, to: determine whether the inner socket walls require mechanical perforations as well as making such perforations exceedingly difficult to carry out.If cortical perforation in order to increase the blood supply to the grafted areas were needed and possible, such perforation would need to be accomplished prior to implant placement.There is no indication that any cortical perforation was carried out prior to implant placement for any of the cases discussed by the dentist.According to the package insert, "after exposure of the bony defect with a full thickness mucoperiosteal flap, all granulation tissue must be carefully removed." therefore, according to the equimatrix package insert, and supported by numerous clinical photos found in the equimatrix brochure, a full-thickness flap is required prior to equimatrix graft particle placement.According to the dentist, all cases grafted with equimatrix were performed "flapless".According to the package insert and included in the equimatrix brochure sent to clinicians, "sites grafted with equimatrix should be allowed to heal approximately 6 months prior to implant placement." in other words, immediate implant placement following tooth removal is not an approved indication when using equimatrix.Of the three cases discussed in some detail, all were immediately placed implants grafted with equimatrix.There is no information about the pre-extraction diagnosis for each area treated.Why the teeth required removal in the first place could impact on the final post-implant and grafting results both in the short and long-term.It appears that all implants in the reported cases received immediate temporary restorations.It is not known if premature loading of the implants was a factor in the graft and implant failure.The periapical and cbct screen shots provided by the dentist for this case show a buccal wall dehiscence on tooth #11 pre-operatively.He said that he extracted this tooth without raising a flap and then grafted the socket with equimatrix and placed an immediate implant.From the data provided, it is unlikely that this procedure could be predictably accomplished and that the buccal wall could be regenerated without a collagen membrane to contain the graft material and maintain space for new bone formation.Furthermore, the dentist also placed an immediate temporary crown on the implant which potentially contributed to the graft and implant failure.In summary, the most likely cause of the graft failure in this case is the improper performance of the clinician.He should not have attempted to treat this site using a flapless approach and instead should have followed a standard gbr protocol.He also selected an implant of improper size and possibly prematurely loaded the implant contributing to the bone loss.Manufacturer product quality assessment: (b)(4) in collaboration with nibec, the manufacturer of equimatrix has conducted an investigation into the equimatrix customer complaints.This investigation included a review of the manufacturing process for the following product batches: uh134011s, uh134292b, uh134322b, uh134332b, uh134392b, and uh134421b.This review included an in-depth review of the batch records and a critical analysis including sterility test, protein assay and endotoxin test, which may be related to the effectiveness of the products.The batch record review indicated that all manufacturing procedures complied with the manufacturing sop with no deviation.The critical biologic analysis performed on the following batches: uh134011s, uh134292b, uh134322b, uh134332b, uh134392b, and uh134421b demonstrated that the product is maintained sterile, the protein content is well below the critical limit, and endotoxin was not detected.Based on the investigation conducted, it can be concluded that no abnormalities could be identified in the manufacturing process and this product has been demonstrated to conform to the current approved specification.A complete company causality assessment and manufacturer product quality assessment have been attached for further review.Upon internal review, it was determined to submit this case as a non-expedited report.This case is linked to (b)(4).
|
