MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-03-27 for GEM 21S manufactured by Luitpold Pharmaceuticals, Inc..
[3257900]
On (b)(4) 2013, a spontaneous report was received by a company rep 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 pts over a period of time and was not a specific lot or product code but the product in general. On (b)(4) 2013, additional info was received by facsimile from the oral surgery assistant forwarded from the dental provider involving a total of 7 pts. This case involves patient #2, (b)(6) female who was a non-smoker. Additional medical history and concomitant medication used were not reported. Teeth numbers 8-11 had been extracted years ago and there was a large deficit. On (b)(6) 2012, equimatrix lot numbers uh114111b and uh114111b were used in all areas. Good closure was achieved. Post treatment medication included hydrocodone and amoxicillin (dose, route, frequency not reported). Equimatrix, used in all areas, "tended to resorb. " re-grafting took place on (b)(6) 2013 (details not provided) and implants had not yet been placed. On (b)(4) 2013, additional info was received by a company dental consultant from the dental provider, an oral and maxillofacial surgeon. Luitpold considered this info to be serious and unexpected. The pt presented with severe resorption of the anterior maxilla which required bone grafting in order to allow implant placement. On (b)(6) 2012, following a midcrestal incision and full-thickness mucoperiosteal flap reflection, the following graft materials were used to graft the buccal and crestal areas of the anterior maxilla: equimatrix 1. 5 grams (lot uh114111b); gem 21s, 3 complete kits (1. 5 cc b-tcp and 1. 5 ml rhpdgf-bb); bio-oss, large particle size (amount unk) and bio-mend membranes were used to cover the site. Luitpold considered all four products to be suspect products. Equimatrix has been reported separately (2013-0065). Primary soft tissue closure was obtained. On (b)(6) 2013, approx 6 months post-grafting, the area was opened with evidence of no new bone formation. According to the dental provider, he was able to distinguish between bio-oss and equimatrix graft particles. Reportedly, some residual equimatrix particulate remained. However, the equimatrix particles had turned yellow and did not appear "normal. " in addition, the dental provider felt that additional anterior maxillary bone resorption occurred following the (b)(6) 2012 graft so that the area appeared clinically more compromised than prior to the graft procedure. On (b)(6) 2013, (previously reported as (b)(6) 2013), the area was re-grafted with equimatrix and rhpdgf-bb (amounts unk). Clinically, soft tissue healing has been uneventful. The area was to be re-evaluated in 4-6 months following the (b)(6) 2013 procedure.
Patient Sequence No: 1, Text Type: D, B5
[10637429]
Due to technical limitations of the database in accommodating more than 3 suspect products, the fourth co-suspect product bio-mend membranes could not be entered into the database under co-suspect product and will not appear in medwatch box c. This case has been linked to 2013-0054, 2013-0065, 2013-0068, 2013-0069, 2013-0070, 2013-0071, 2013-0072, 2013-0075, 2013-0077, 2013-0078, 2013-0131, 2013-0136, 2013-0139, 2013-0140 and product quality case 2013-0053.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2410375-2013-00003 |
| MDR Report Key | 3030528 |
| Report Source | 00,05 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-03-27 |
| Date of Event | 2012-08-29 |
| Date Mfgr Received | 2013-03-01 |
| Date Added to Maude | 2013-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | P.O. BOX 9001 |
| Manufacturer City | SHIRLEY NY 11967 |
| Manufacturer Country | US |
| Manufacturer Postal | 11967 |
| Manufacturer Phone | 6319244000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEM 21S |
| Generic Name | NONE |
| Product Code | NPZ |
| Date Received | 2013-03-27 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUITPOLD PHARMACEUTICALS, INC. |
| Manufacturer Address | ONE LUITPOLD DR. P.O. BOX 9001 SHIRLEY NY 11967 US 11967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-27 |