FDA Adverse Event Injury Summary report: N

GRAFTON (DBM) MATRIX 2.5CM X 10CM

MDR report key: 3379150 · Received September 26, 2013

Report

Report Number
MW5032059
Event Type
Injury
Date Received
September 26, 2013
Date of Event
January 9, 2013
Report Date
September 25, 2013
Manufacturer
OSTEOTECH
Product Code
MQV
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
IA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

ON (B)(6) 2012, PRE-OP ABX ADMINISTERED, ANCEF, 2G. LUMBAR DECOMPRESSION (LAMINECTOMY) OF THE L3-L5 AND A SPINAL FUSION (L4-L5) TLIF WERE PERFORMED. THE SURGICAL SITE WAS THOROUGHLY IRRIGATED. AUTOGRAFT MIXED WITH ALLOGRAFT (GRAFTON DBM) WAS PLACED IN THE LATERAL GUTTERS BETWEEN THE TRANSVERSE PROCESSES AT L4-L5 AND COMPACTED MANUALLY. ON (B)(6) /2013, PT PRESENTED TO LOCAL ER WITH ACUTE ONSET OF LOWER PACK PAIN RADIATING DOWN TO BUTTOCKS AND KNEES. PT REPORTED BEING AFEBRILE. INFLAMMATORY MARKERS WERE ELEVATED. PT WAS GIVEN A DOSE OF ZOSYN. MRI SHOWED DIFFUSE T1 INCREASED UPTAKE AROUND WOUND COMPATIBLE WITH POSTSURGICAL INFLAMMATORY CHANGES OR EARLY INFECTIOUS-TYPE INFLAMMATORY PROCESS. NO GROSS FLUID COLLECTION/ABSCESS. SURGICAL WOUND EXAM: MILDLY TENDER, MILD REACTIVE ERYTHEMA AROUND THE WOUND. AT THE DISTAL ASPECT OF THE WOUND, APPROX 0.5 MM AREA OF DEHISCENCE WHICH APPEARED SUPERFICIAL, NO ACTIVE DRAINAGE. ON (B)(6) 2013, A CT GUIDED ASPIRATE OF FLUID COLLECTION SHOWED HIGH NEUTROPHIL COUNT AND GPC, GPR PRESENT (DIPHTHEROIDS). PROCEEDED WITH I&D ON (B)(6) 2013, PRE-OP ANTIBIOTICS GIVEN, 2G ANCEF. INCISED ORIGINAL INCISION, SMALL AREA OF DEHISCENCE AT INFERIOR ASPECT OF WOUND. ENCOUNTERED A SIGNIFICANT AMOUNT OF PURULENT DRAINAGE AT THE DEEP DERMAL LAYER, WHICH WAS CONNECTED TO A FASCIAL DEHISCENCE SUPERIORLY. NO PURULENT DRAINAGE NOTED FROM THE AREA OF THE L4/L5 DISC SPACE. SOME SURROUNDING NECROTIC TISSUE IN THE FATTY LAYER WHICH WAS DEBRIDED AND WOUND WAS IRRIGATED. CALCIUM-SULFATE ANTIBIOTIC BEADS WERE PLACED LATERAL TO THE RODS. CLOSED SUBCUTANEOUS TISSUE, ANTIBIOTIC BEADS ALSO PLACED OVER FASCIAL LAYER, WOUND VAC PLACED ON INCISIONAL WOUND. PLACED ON VANCO AND CIPRO PER ID ADVICE, CONTINUED FOR 2 MONTHS DURING WHICH TIME WOUND HEALED COMPLETELY. DIAGNOSIS OR REASON FOR USE: SPINAL FUSION PROCEDURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
486621 GRAFTON (DBM) MATRIX 2.5CM X 10CM MQV OSTEOTECH OTSCT1108064035

Patients

Seq Age Sex Outcome Treatment
1 81 YR Hospitalization