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Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)
Event Date 11/20/2018
Event Type  Injury  
Manufacturer Narrative
(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.
Event Description
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 superficial 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 does not opine that the barbed suture or the topical skin adhesive is causing the event. 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.
Manufacturer Narrative
Date sent to fda: 2/1/2019. Additional information was requested and the following was obtained: does the surgeon believe that any ethicon product contributed to the infection? no the surgeon believes it was due to the insufficient closure due to technique that caused the wound infection. Procedure (primary): (b)(6). Primary diagnosis: non-union right sacroiliac fusion procedure: removal of fibrous fusion mass & (b)(6). Right sacroiliac joint distraction/fixation & fusion. Right s1-s4 posterolateral fusion. Implants: crunch, infuse, (b)(6) (signus). Wound closure:1 prolene stratafix/2. 0 stratafix/prineo. Patient notes: (b)(6) 2018: patient phoned the rooms - she had removed the prineo dressing & replaced this with a tegarderm & haemoserrous ooze. Emailed photos to the room - prineo still insitu, small area of non-union along the cranial end of the suture line- for re-suturing. Procedure 2: (b()(6) (new admission). Primary diagnosis: lumbar wound breakdown. Procedure 2: re-suture lumbar wound. Wound closure: 2. 0 nylon.
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Manufacturer (Section D)
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8163311
MDR Text Key130318728
Report Number2210968-2018-77756
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1