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(b)(4).
To date, the device has not been returned.
If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional information was requested and the following was obtained: date the event occurred? n/k.
Please confirm was is meant be insufficient closure? is this technique related or improper closure? technique related.
Dr (b)(6) advised that there were a few factors that has contributed prineo being removed too early by staff or moisture and rolled off (re-trained).
Insufficient closure leaving dead space (re-trained assistant).
Is the wound dehiscence being attribute to the stratafix? no.
Did the patient have any pre-existing health issues that could contribute to healing issues which could have contributed to the event? for example, medications, past reactions or allergies, weight, age, diabetes, obesity, etc? n/k.
Did the patient fall or injury themselves in a way that may have affected the surgical area? no.
Was the patient compliant with post-op instructions? n/k.
What type of medical intervention was provided by the surgeon? what precisely was done as part of the intervention? re-closure? what is the patient¿s current condition? tba.
How long post-op did the patient present with symptoms for each of the cases? approx 2 weeks.
Has surgeon been trained on the product? yes.
What is the procedure name and initial procedure date? spinal procedure.
What date did the dehiscence occur on? about 2 weeks post-op.
Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.
Re-closure.
What is the most current patient status? n/k.
Can you identify the product code and lot number of the product that was used? tba.
Additional information was requested and the following was obtained: was there any alleged product deficiency relating to the prineo? reason that the prineo was accidently removed/ rolled off or removed? product code and lot number of prineo used? was there any stratafix suture deficiency (breakage) noted related to the wound dehiscence? please explain what layer experienced the wound dehiscence? was there any alleged product deficiency relating to the stratafix suture? will actual samples be returned for evaluation? will any unopened representative samples be returned for evaluation?.
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It was reported that a patient underwent a spinal procedure on an unknown date and topical skin adhesive was used.
Approximately two weeks post op, the patient came back with wound dehiscence.
The topical skin adhesive may have been removed accidently by agency staff at ward or rolled off due to moisture/sweat too early.
The patient was resutured.
The surgeon used barbed suture for fascia and muscle and another barbed suture for subcutaneous/subcuticular closure.
The surgeon used topical skin adhesive on skin.
The surgeon reports that the wound dehiscence is not attributed to the barbed suture.
The surgeon opines that the dehiscence is technique related or possibly due to insufficient closure leaving dead space in the subcutaneous layer or the topical skin adhesive being taken off at wards before its supposed to.
The staff has been given thorough education.
The surgeon has started to close fascia / muscle, subcutaneous and subcuticular with barbed suture.
Additional information has been requested.
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Product complaint # (b)(4).
Date sent to fda: 1/21/2019.
Additional information was requested and the following was obtained: hospital/date: (b)(6) 2018.
Primary diagnosis: c5-c7/t1 instability.
Procedure 1: c5-t1 fixation & posterolateral fusion; c7/t1 foraminotomy/decompression.
Implant si floseal, crunch, yukon screws & lateral offset connectors (lhc), bone graft.
Wound closure: 1 stratafix/2.
0 stratafix/prineo.
Patient notes: (b)(6) 2018: post-op ct.
(b)(6) 2018: wound swab.
Microbiology indicates light growth of staph aureus.
(b)(^) 2018: blood cultures negative.
(b)(6) 2018: mri c spine for wound breakdown: no fluid collection.
Procedure 2: hospital/date: (b)(6) 2018 (current inpatient).
Primary diagnosis: cervical wound breakdown.
Procedure 2: debride & re-suture cervical wound.
Wound closure:1 vicryl/1 vicryl/2.
0 vicryl/3.
0 nylon/tension sutures.
Antimicrobial therapy: iv abs.
Patient notes : home with health choices.
Follow-up appointments: (b)(6) 2018: practice nurse.
(b)(6) 2019: dr.
(b)(6).
Will actual samples be returned for evaluation? no.
Will any unopened representative samples be returned for evaluation? no.
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