MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: SPINE; PLATE, FIXATION, BONE

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

Patient Problems Nerve Damage (1979); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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: sengupta, d.K., khazim, r., grevitt, m.P.And webb, j.K.(2001), flexion osteotomy of the cervical spine: a new technique for correction of iatrogenic extension deformity in ankylosing spondylitis, spine, vol.26 (9), pages 1068-1072 ((b)(6)).This study presents a case report of a (b)(6) year-old female patient who had global kyphotic deformity caused by ankylosing spondylitis underwent a flexion osteotomy of the cervical spine.Surgery was performed using cervical spine locking plate (stratec ltd., welwyn garden city, uk).Paraesthesia developed in the patient¿s right c8 and t1 dermatomes during the immediate postoperative period.This problem was settled completely with halo-traction for two weeks.Immobilization was maintained with a halo-vest for 8 weeks, followed by a molded collar for another 6 weeks.At the 2-year follow-up assessment, the patient had no further complication, and her gaze angle was fully corrected.This report is for an unknown synthes plate.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: SPINE
• Type of Device: PLATE, 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: 9010141
• MDR Text Key: 162332558
• Report Number: 8030965-2019-68223
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

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: 08/15/2019
• Initial Date FDA Received: 09/12/2019
• 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: 44 YR