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 Spinal Column Injury (2081); No Code Available (3191)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(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: xu c., et al (2020) the relationship between preoperative cervical sagittal balance and clinical outcome of laminoplasty treated cervical ossification of the posterior longitudinal ligament patients, the spine journal 000 , pages 1-8 (china).Https://doi.Org/10.1016/j.Spinee.2020.05.542.This retrospective study aims to assess several cervical sagittal balance parameters to determine whether preoperative cervical sagittal alignment affects the clinical outcomes after laminoplasty in patients with opll.Between january 2015 and january 2017, a total of 287 patients who underwent cervical laminoplasty for opll were reviewed.Among them, 181 consecutive patients (126 males and 75 females) with mean age of 63.2 years (range 44 -82) who had undergone posterior laminoplasty were included in the present study and finished the 2-year follow-up.All patients underwent expansive open-door laminoplasty using an arch plate fixation system (depuy synthes) at c3-6 in 154 patients and at c3 -7 in 27 patients.The following complications were reported as follows: the lowest quarter of patients with the least joa recovery rate were included in the least improved group (45 cases, joa recovery rate 24.2 17.2).38 patients exhibited a postoperative lordosis loss in cervical alignment and were included in the lordosis decreased group, while the other 143 patients were included in the lordosis sustained group.21 patients had kyphotic cervical alignment (c2-c7 cobb angle <0°, 18 to 2° in c2-c7 cobb angle) at the final follow-up, which was more than that preoperatively.This report is for an unknown synthes screws.It captures 38 patients who exhibited a postoperative lordosis loss in cervical alignment and 21 patients who had kyphotic cervical alignment.This is report 2 of 2 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10364878
• MDR Text Key: 207531533
• Report Number: 8030965-2020-05613
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• 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