MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Weakness (2145); No Code Available (3191)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, lot #, part #, udi #, 510k: this report is for a pedicle screw internal fixation system/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: 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: li, y.Et al (2019), "progressive pseudorheumatoid dysplasia confirmed by whole-exon sequencing in a chinese adult before corrective surgery." journal of orthopaedic surgery and research, vol.22, no.4, pages 452-458 (china).This study presents a case report of a (b)(6) male with a progressive pseudorheumatoid dysplasia (ppd), initial signs of and symptoms appeared when he was (b)(6).Diagnosis of juvenile rheumatoid arthritis (jra) was considered by local hospitals, and glucocorticoids were prescribed without efficacy.He had to walk with crutches at (b)(6) because of arthritis of the lower extremities.At (b)(6), he first experienced progressive pain with numbness radiating down his entire left leg and right thigh.At (b)(6), he started to have mild difficulty in urination.Treatment with tramadol, physical therapy, and spine injection were tried but were not effective.His visual analogue scale (vas) score was 9.Physical examination showed multiple malformations of the major limb joints, especially of the knees and hands.Amyotrophy of both lower limbs was obvious.Dysesthesia was found in the posterolateral left calf, dorsolateral left foot, and perineal area.Tests for rheumatoid factors were negative.Spinal x-rays showed flat and osteoporotic vertebral bodies, mri showed multilevel schmorl nodes.Mucolipidosis type iv was suspected according to clinical presentations.Both physical examination and imaging indicated lumbar canal stenosis, a decompressive laminectomy and posterior-lateral fusion from l2 to s1 was performed.After the operation, leg pain was decreased, and vas score was decreased to 1 without any surgical complications.With the help of rehabilitation training, the patient regained the ability to walk with the help of crutches.Five years after the surgery, the patient began to feel stiffness and weakness of the lower extremities.His symptoms progressed for several months, and he lost ambulatory ability again.Physical examination revealed positive babinski sigh, hypesthesia below the xiphoid level, hypermyotonia, and extensive muscle weakness of the lower extremities.The patient underwent surgery again, during which decompressive laminectomy from t2 to l2 was performed and kyphosis correction was achieved by resecting the facet joints with circumferential decompression at the t5-6 level.Zonesthesia and hypermyotonia of the lower extremities improved postoperatively, but muscle weakness did not improve.At the latest follow-up, 1 year after the second surgery, the frankel classification was still grade b.This report is for a pedicle screw internal fixation system.This is report 1 of 1 for (b)(4).

• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 8565542
• MDR Text Key: 143689751
• Report Number: 8030965-2019-63287
• Device Sequence Number: 1
• Product Code: MNH
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/30/2019
• 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
• Patient Age: 35 YR