MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; SCREW,FIXATION,BONE

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

Patient Problems Dysphagia/ Odynophagia (1815); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between july 2011 and august 2019.Complainant part is not expected to be returned for manufacturer review/investigation.The author of this literature article is unknown because it is part of the british spine registry.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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: evaluation of healthcare outcomes of patients implanted with ecd-expandable corpectomy device during surgical fusion procedures of the cervical and upper thoracic spine: a real-world evidence external registry review, british spine registry ecd report, vol.Xx pages 1-15 (united kingdom).This study provides a descriptive assessment of patients implanted with expandable corpectomy device (ecd) during surgical procedures of the cervical and upper thoracic spine, as analyzed from the british spine registry (bsr).Between july 2011 and august 2019, a total of 21 patients (11 males and 10 females) underwent anterior corpectomy procedures.The mean age was 60.8 years.There were eight patients who received ecd for cervical corpectomy for the treatment of tumor.Additionally, 4 patients where treated with ecd for trauma and 9 patients where treated for cervicothoracic degenerative disease.Depuy synthes ecd corpectomy cage, depuy synthes cslp plate, axon pedicle screw system and depuy synthes synapse posterior cervical fixation.The article did not specify which of the devices were being used to capture the following complications: 1 patient had an intraoperative dural tear.1 patient had a pulmonary embolism.There was intraop excessive bleeding-incomplete tumour resection.Complication was noted as a result of a reoperation to adjust the halo following the index surgery.In the case where surgeons performed an adjustment of the halo, staff noted ¿dysphagia that occurred after second procedure¿.This patient required a reoperation.The procedure described as ¿adjustment of a halo and not for the removal of metalwork¿.This report is for an unknown synthes ecd corpectomy cage, depuy synthes cslp plate, axon pedicle screw system and depuy synthes synapse posterior cervical fixation.(b)(4).This report is for one (1) unknown screw.This is report 3 of 5 for (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10402706
• MDR Text Key: 209840542
• Report Number: 8030965-2020-05932
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• 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