UNKNOWN MICROMATRIX
Report
- Report Number
- 3005920706-2025-00002
- Event Type
- Injury
- Date Received
- February 12, 2025
- Report Date
- March 28, 2025
- Manufacturer
- INTEGRA - ACELL(COLUMBIA)
- Product Code
- KGN
- PMA / PMN Number
- K172399
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UPDATED FIELDS. THE MICROMATRIX WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, POTENTIAL ROOT CAUSES INADEQUATE COVERAGE DURING INITIAL APPLICATION OF THE MICROMATRIX OR INADEQUATE COVERAGE DURING SUBSEQUENT APPLICATIONS AS THE STUDY CONCLUDES THAT THE PRIMARY WOUND COVERAGE FAILURE WAS RELATED TO WOUND SIZE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
N/A
THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBER: 1121308-2025-00004, 3005920706-2025-00003. THE EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY (2024) PUBLISHED "URINARY BLADDER MATRIX VERSUS DERMAL REGENERATION TEMPLATE FOR LOWER EXTREMITY WOUND COVERAGE." THE PURPOSE OF THIS STUDY IS TO COMPARE DERMAL REGENERATIVE TEMPLATE (DRT), WITH AND WITHOUT SPLIT-THICKNESS SKIN-GRAFTING (STSG), AND URINARY BLADDER MATRIX (UBM) FOR COVERAGE OF LOWER EXTREMITY WOUNDS. METHODS: A RETROSPECTIVE REVIEW OF 56 LOWER EXTREMITY WOUNDS TREATED WITH EITHER DRT AND STSG (DRT-S) (N =18), DRT ONLY (N=17), OR UBM ONLY (N=21). PATIENT CHARACTERISTICS, COMORBIDITIES, AMERICAN SOCIETY OF ANESTHESIOLOGY (ASA) CLASSIFICATION, INJURY CHARACTERISTICS, WOUND CHARACTERISTICS, USE OF NEGATIVE PRESSURE WOUND THERAPY, SURGICAL DETAILS, POSTOPERATIVE CARE, AND FAILURE OF PRIMARY WOUND COVERAGE PROCEDURE WERE DOCUMENTED. RESULTS: THE DRT GROUP, COMPARED TO THE DRT-S GROUP, WAS OLDER (MEDIAN DIFFERENCE (MD) 17.4 YEARS, 95% CONFIDENCE INTERVAL (CI) 9.1-25.7; P=0.0008), MORE DIABETIC (PROPORTIONAL DIFFERENCE (PD) 54.2%, CI 21.2-76.1%; P=0.002), HAD SMALLER WOUNDS (MD -91.0 CM2, CI -125.0 TO -38.0; P=0.0008), MORE INFECTED WOUNDS (PD 49.0%, CI 16.1-71.7%; P=0.009), A SHORTER LENGTH OF STAY AFTER COVERAGE (MD -5.0 DAYS, CI -29.0 TO -1.0; P=0.005), AND NO DIFFERENCE IN PRIMARY WOUND COVERAGE FAILURE (41.2% VS. 55.6%; P=0.50). THE UBM GROUP, COMPARED TO THE DRT GROUP, WAS YOUNGER (MD -6.8 YEARS; CI -13.5 TO -0.1; P=0.04), HAD FEWER PATIENTS WITH AN ASA HIGHER THAN 2 (PD -35.0%, CI -55.2% TO -7.0%; P=0.02), DIABETES (PD -49.2%, CI -72.4% TO -17.6%; P=0.003), AND HAD NO DIFFERENCE IN PRIMARY WOUND COVERAGE FAILURE (36.4% VS. 41.2%; P=1.0). FAILURE OF PRIMARY WOUND COVERAGE WAS FOUND TO ONLY BE ASSOCIATED WITH LARGER WOUND SURFACE AREAS (MD 22.0 CM2, CI 4.0-90.0; P=0.01). CONCLUSIONS: DRT AND UBM COVERAGE HAD SIMILAR RATES OF PRIMARY WOUND COVERAGE FAILURE FOR LOWER EXTREMITY WOUNDS. THIS REPORT IS FOR: ADVERSE EVENT/MALFUNCTION (MICROMATRIX): FAILED PRIMARY WOUND COVERAGE WITH THE ASSOCIATED HARMS OF INFECTION AND REVISION SURGERY. HTTPS://DOI.ORG/10.1007/S00590-024-03888-9.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 895766 | UNKNOWN MICROMATRIX | MICROMATRIX | KGN | INTEGRA - ACELL(COLUMBIA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |