EQUIMATRIX CANCELLOUS (8503-06-0025)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-03-28 for EQUIMATRIX CANCELLOUS (8503-06-0025) manufactured by .

Event Text Entries

[3323703] On (b)(6) 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)(6) 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, a (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)(6), 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. Gem 21s has been reported separately (b)(4). 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


[10610502] 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. This case has been linked to (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2410375-2013-00002
MDR Report Key3030522
Report Source00,05
Date Received2013-03-28
Date of Report2013-03-27
Date of Event2012-08-29
Date Mfgr Received2013-02-20
Device Manufacturer Date2012-03-01
Date Added to Maude2013-04-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer StreetP.O. BOX 9001
Manufacturer CitySHIRLEY NY 11967
Manufacturer CountryUS
Manufacturer Postal11967
Manufacturer Phone6319244000
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEQUIMATRIX CANCELLOUS (8503-06-0025)
Generic NameNONE
Product CodeNPM
Date Received2013-03-28
Lot NumberUH114111B
Device Expiration Date2015-02-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-03-28

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