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

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown spine screws / unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review / investigation.(b)(6).(b)(4).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.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: cavali, p.T.M., landim, é., pasqualini, w.And veiga, i.G.(1998), anterior cervical arthrodesis with morscher* plate: experience in 44 cases, revista brasileira de ortopedia, vol.33 (2), pages 101-105 (brazil).The aim of this study is to report our experience and the results obtained using the morscher plate in several cervical pathologies.A total of 44 patients (27 male and 17 female) with a mean age of 46 years (range: 16-78) were included in the study.Surgery was performed using a cervical spine locking plate (cslp).The follow-up period was an average of 20 months (ranging from 6 to 48 months).The following complications were reported as follows: the patients with tetraplegia did not show any improvement in the neurological injury.A patient had loosening of a cranial screw and a caudal screw without loosening of the plate three months after surgery and presented with dysphagia.The patient underwent further surgery to remove the implants.A female patient had loosening of the two caudal screws and of this end of the plate four months after surgery, with dysphagia.She underwent further surgery to remove the implants.A patient had a plate fracture 10 months after surgery and presented with cervical pain.A patient had loosening of the two screws at the caudal end with loosening of this end of the plate three months after surgery.A patient had loosening of a screw at the caudal end of the plate.This is report 7 of 7 for (b)(4).This report is for unknown synthes spine screws.

• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8949604
• MDR Text Key: 157343848
• Report Number: 8030965-2019-67869
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2019
• 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