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 Cerebrospinal Fluid Leakage (1772); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 05/30/2014

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown spine plates/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: thakar, s.Et al (2014), paraspinal muscle morphometry in cervical spondylotic myelopathy and its implications in clinicoradiological outcomes following central corpectomy, journal of neurosurgery: spine, vol.21 (2), pages 223-230 (india).The aim of this retrospective study is to assess the cross-sectional areas (csas) of the superficial, deep flexor (df), and deep extensor (de) paraspinal muscles in patients with cervical spondylotic myelopathy (csm), and to evaluate their correlations with functional status and sagittal spinal alignment changes following central corpectomy with fusion and plating.Between 2002 to 2012, a total of 67 patients (61 male and 6 female) with a mean age of 52 ± 10.37 years underwent central corpectomy, fusion, and plating.Surgery was performed using cslp (synthes) or a competitor's device.The mean duration of follow-up was 20.48 ± 11.25 months (range 6¿90 months).The following complications were reported as follows: 8 patients had pseudarthrosis.The mean sacf, however, demonstrated a mean kyphotic change of -3.07° ± 6.78° (range +15° to -22.5°).Whereas kyphotic change occurred in 24 patients (35.82%), significant sacf (> 10°) occurred in 16 patients (23.88%).3 patients had transient c-5 radiculopathy.1 patient developed a recurrent laryngeal nerve paresis that resolved within 3 months.4 patients had wound-related problems (1 incisional hernia at the iliac bone graft site and 3 cases of superficial iliac bone graft site infection).2 patients had an intraoperative csf leak were managed successfully with conservative treatment.This report is for an unknown synthes spine plates.It captures the adverse events of nonunion, kyphosis, nerve injury, csf leak and surgical intervention.This is report 1 of 2 for complaint (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: 9517073
• MDR Text Key: 188676483
• Report Number: 8030965-2019-71438
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• 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: 12/05/2019
• 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