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 Cerebrospinal Fluid Leakage (1772); Pain (1994); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/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.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.

Event Description

This report is being filed after the review of the following journal article: chen y, et al.(2020), comparison of anterior controllable antidisplacement and fusion (acaf) with posterior laminoplasty in the treatment of multilevel cervical ossification of the posterior longitudinal ligament: a prospective, randomized and control study with at least one-year follow up, spine an international journal for the study of the spine, page 1-21, (china).This study aims to compare anterior controllable antidisplacement and fusion (acaf) with laminoplasty in the treatment of multilevel ossification of the posterior longitudinal ligament (opll), and evaluate the efficacy and safety of this procedure.Between september 2016 and april 2018, 80 patients with multilevel ossification of the posterior longitudinal ligament (opll) were included in the study.These patients were randomized in a 1:1 ratio to anterior controllable antidisplacement and fusion group (acaf) and laminoplasty group.In the acaf group, there were 40 patients (23 males and 16 females) with a mean age of 54.6+/-11.2 years.These patients underwent fixation using a depuy spine skyline anterior cervical plate system with peek cage.After surgery, all patients were immobilized in a philadelphia collar for 6-8 weeks.Meanwhile, in the laminotomy group, there were 40 patients (20 males and 18 females) with a mean age of 57.2 +/-10.4 year.These patients underwent fixation using an unknown synthes arch miniplate fixation system.After surgery, all patients were immobilized in a philadelphia collar for 3-4 weeks.The outpatient follow-up was routinely carried out at the time of 3, 6 and 12 months postoperatively, and the final visit was set as 12 months postoperatively.The overall follow-up period of the patients ranged from 12 to 30 months (average 18.6 +/- 4.5 months).Complications were reported as follows: 2 patients had cerebrospinal fluid leakage.3 patients had c5 palsy.7 patients had axial pain.1 patient had hoarseness.This report is for an unknown synthes screw.This is report 2 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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: 10449841
• MDR Text Key: 211639644
• Report Number: 8030965-2020-06290
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 07/30/2020
• 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