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Device Problem No Apparent Adverse Event (3189)
Patient Problems Dysphagia/ Odynophagia (1815); Pocket Erosion (2013)
Event Date 09/07/2005
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plate/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. 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. (b)(4).
Event Description
This report is being filed after the review of the following journal article: von rahden b. , stein h. , (2005), late hypopharynx-esophageal perforation after cervical spine surgery: proposal of a therapeutic strategy, european spine journal, volume 14, pages 880¿886 (germany). This study presents a case report of 3 patients to propose a flow sheet for an interdisciplinary surgical strategy based on experience with this rare complication in a high-volume center with vast exposure to esophageal surgery. A case of a (b)(6)-year-old woman presented in (b)(6) 2002 with moderate dysphagia, lasting for at least 1 month. Flexible endoscopy revealed a perforation of the cervical esophagus, immediately below the upper esophageal sphincter. The patient had undergone cervical spine fusion (c5¿ th1) and plate fixation 3. 5 years before. Anterior cervical spine fusion had been performed using autogenic bone from the iliac crest and fixation with an anterior plate. The defect of the posterior esophageal wall, just below the upper esophageal sphincter, measured 3 cm in length. The osteosynthesis material was clearly visible during examination with flexible endoscopy. An anterior plate, penetrating through the posterior wall of the cervical esophagus into the lumen, was demonstrated by means of flexible endoscopy (left side). On computer tomography (right side) the osteosynthesis material was shown to be incorrect position. Below the perforation site, there was esophageal stenosis, which could only be passed with a thin pediatric endoscope. Screws and plate were in the proper position. There were no signs of dislocation on conventional x-ray and ct scan imaging the patient was operated through a left-sided cervical approach. The osteosynthesis material could be removed since the fracture site showed complete union. Reconstruction was done with a free jejunal loop (end-to-end anastomosis with the cervical as well as the distal esophageal stump). The further surgical course was uneventful, except for dysphagia, due to a stenosis of the proximal anastomosis. This could successfully be managed by endoscopic dilatation. A case of a severely ill (b)(6)-year-old female patient, suffering from a stage iiib plasmacytoma (first diagnosis (b)(6) 2001). In (b)(6) 2001, the patient had undergone corpectomy of the almost completely destroyed vertebrae c4 and c5, which had been infiltrated by the plasmacytoma. For stabilization of the spine, the patient had undergone spondylodesis of c3¿c6 using a harmscage, pmma and a morscher-plate. This osteosynthesis had been redone 2 months postoperatively when dislocation of the harms-cage had occurred. Revisional surgery was performed with bone cement (palacos) and an anterior plate. In (b)(6) 2003, the patient was admitted to our hospital for treatment of a hypopharyngeal perforation due to penetration of the anterior plate into the hypopharynx. She was afebrile and showed no signs of local, mediastinal or generalized infections. This was an incidental finding during flexible endoscopy (left side). The perforation was also detectable on cervical ct scan that, furthermore, showed the otherwise proper position of the osteosynthesis material. On repeat endoscopy, the perforation site was demonstrated to be localized in the hypopharynx, 2 cm below the piriform sinus. It was decided to perform a two-stage procedure (see fig. 3). First, the patient was operated via a posterior approach. She received craniocervical posterolateral fusion using the cervifix system and allogenous spongious bone. Two weeks later, the anterior plate was removed and the hypopharyngeal wall was repaired by direct suture. The postoperative course of the patient was uneventful. The integrity of the suture line was demonstrated using pharyngoesophagography. The patient was discharged home 3 weeks postoperatively when oral food intake was possible. This report is for an unknown synthes screw. This is report 3 of 4 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key9135589
MDR Text Key165974771
Report Number8030965-2019-68845
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/30/2019 Patient Sequence Number: 1