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 Problem Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/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: liu x, et al.(2019), extended laminoplasty for ossification of posterior longitudinal ligament involving the c2 segment, world neurosurgery, volume 130, page 317-323, (china) this study aims to evaluate the effectiveness and safety of extended laminoplasty for the treatment of ossification of the posterior longitudinal ligament (opll) involving the c2 segment.From january 2010 to january 2015, a total of 132 patients who underwent laminoplasty for the treatment of multilevel posterior longitudinal ligament (opll) were included in the study.The patients were divided into 3 groups (a, b, & c) according to the involvement of the opll and extent of the laminoplasty.In group a, there were 26 patients (19 males and 7 females, mean age of 59.6 +/-12.2 years) with c2 opll and c2-c7 laminoplasty.In group b, there were 29 patients (23 males and 6 females, mean age of 57.8 +/-11.6 years) with c2 opll and c3-c7 laminoplasty.In group c, there were 77 patients (59 males and 19 females, mean age of 57.4 +/- 11.3 years) without c2 opll and had c3-c7 laminoplasty.All patients underwent fixation using an unknown synthes arch mini-plates.All cases in the 3 groups wore a philadelphia collar for 2-4 weeks and then started neck function exercises.The outpatient follow-up was carried out at 3, 6, and 12 months postoperatively, and then once per year thereafter, and the final visit was set at 3-years postoperatively.Complications were reported as follows: (group a) 1 patient had incision infection which completely healed after dressing change and usage of intravenous antibiotics for less than 1 week.46.2 percent of patients had an incidence of axial pain.Unknown patients had neck pain.(group b) 1 patient had c5 palsy which received complete relief after 2 months¿ hyperbaric oxygen therapy and then 6 months¿ rehabilitation exercise.20.1 percent of patients had an incidence of axial pain.Unknown patients had neck pain.(group c) 3 patients had incision infection which completely healed after dressing change and usage of intravenous antibiotics for less than 1 week.2 patients had c5 palsy which received complete relief after 2 months¿ hyperbaric oxygen therapy and then 6 months¿ rehabilitation exercise.1 male patient had early deterioration in limb muscle strength bilaterally due to c4 lamina closure before tracheal extubation, and he received immediate recovery after revision laminectomy at c4.22.1 percent of patients had an incidence of axial pain.Unknown patients had neck pain.This report is for an unknown synthes arch miniplate fixation system.This is report 3 of 4 for (b)(4).This impacted product capture the reported male patient who had early deterioration in limb muscle strength and was revised with laminectomy at c4.

• 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: 10456159
• MDR Text Key: 212871329
• Report Number: 8030965-2020-06338
• Device Sequence Number: 1
• Product Code: HRS
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 07/31/2020
• 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