|
On (b)(6) 2015, an initial, spontaneous report was received by (b)(4) from a dentist via an email from a sales representative concerning the third 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 case report was referenced by the dentist as case #3 (the third of 8 patients) which involved teeth #'s 8 and 9, the maxillary right and left central incisor teeth that were removed.Implants were placed immediately after extraction and the gap between the implant bodies and alveolar walls were grafted with equimatrix.At one month, the patient felt the area was swollen and inflamed (meddra: swelling and inflammation, respectively) and experienced significant pain (meddra: pain).The area was probed and found a 15 mm defect on the palatal aspect of each implant (meddra:palatal disorder).No purulent drainage was noted.Both implants were removed (meddra: device failure), revealing copious amounts of granulation/inflammatory tissue (meddra: excessive granulation tissue and soft tissue inflammation, respectively).In addition, the interseptal bone between areas #8 and 9 was completely resorbed and gross amounts of resorbed palatal were noted, exposing the buccal portions of the patient's incisive canal (meddra: bone loss).According to the dentist, the labial plate of bone was completely resorbed for both #8 and 9 areas.The dentist redid the case, placing new implants into the nasal floor and grafting with mineralized allograft.The dentist considers the equimatrix related to the events.Upon medical review, the dentist considers the following serious (required intervention): 15 mm defect on palatal aspect of each implant, implant removed and gross amounts resorbed palatal bone, labial plate of bone completely resorbed number 8 and 9 area.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 dr.Jain 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 the 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.In this case there were no supporting radiographic or cbct images provided by the dentist.From his description, it appears that there may not have been sufficient primary stability of the immediate implants to immobilize them with the temporary crowns in place.The jiggling forces on the implants during function would account for the granulation tissue and inflammatory response.Leaving this situation untreated for a month could account for the deep probing and bone loss he described.It is difficult to reconcile the dentist's handling of these complications by placing new implants "into the nasal floor" and grafting with mineralized allograft.In summary, the graft failure and complications in this case are due to the improper performance of the clinician and not related to the equimatrix.Manufacturer product 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 pv case report numbers: (b)(4).
|
