MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: ANTERIOR TENSION BAND; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: anterior tension band/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: santiago-dieppa dr, et al.(2014), l4 and l5 spondylectomy for en bloc resection of giant cell tumor and review of the literature, evidence-based spine-care journal, volume 5, no.2, pages 151-157, (usa).The objective of this study is to present the case of a two-level lumbar spondylectomy at l4 and l5 for en bloc resection of a giant cell tumor and lumbopelvic reconstruction.This reports a case of a (b)(6) year-old woman who was found to have a primary isolated giant cell tumor involving the l4 and l5 vertebral bodies.A spondylectomy that achieved en bloc resection of the tumor followed by lumbopelvic reconstruction was recommended to optimize the patient¿s chance of disease-free survival.Such a procedure would be executed in 2 stages.During stage 1 procedure, a midline posterior approach was performed with bilateral exposure from l2¿s2.The unknown depuy spine expedium pedicle screw instrumentation was placed at l2, l3, and s1 bilaterally and the spondylectomy procedure was performed using other competitors' devices.During stage 2 procedure, a retroperitoneal dissection was performed for mobilization of the aorta, vena cava, and iliac vessels to achieve wide anterior exposure of the l3¿s1 segments.The anterior reconstruction of the spinal column was performed using competitors¿ devices and was completed by installing the unknown synthes anterior tension band (atb) plate that spanned 101 mm in length from l3 to s1.There were no immediate complications from the procedure, and the patient remained neurologically intact.The patient was discharged to rehab on hospital day 14.On postoperative day 16, dehiscence and serous drainage from the inferior aspect of the posterior wound was noted.Due to concern for a possible deep wound infection, the patient was taken back to the opting room and the wound was reopened, irrigated, and debrided.Operative cultures obtained later revealed a complicated deep wound infection with corynebacterium for which the patient was treated with an extended course of vancomycin and cefepime.3 days after the debridement surgery, the patient was found to have a cerebrospinal fluid leak, which was successfully treated with a temporary lumbar drain.At 28 months of follow-up, the patient was neurologically intact and ambulatory without any evidence of giant cell tumor recurrence or instrumentation failure.This report is for the unknown synthes anterior tension band (atb) plate.This report is for (1) unk - plates: anterior tension band.This report is 1 of 1 for (b)(4).Related product complaint: (b)(4).

• Brand Name: UNK - PLATES: ANTERIOR TENSION BAND
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12433764
• MDR Text Key: 270488710
• Report Number: 2939274-2021-05214
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR