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 Unspecified Infection (1930); Pain (1994); Paresis (1998); Weakness (2145); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown spine screws/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: grob, d.And humke, t.(1998), translaminar screw fixation in the lumbar spine: technique, indications, results, european spine journal, vol.7 (3), pages 178-186 (switzerland).The aim of this study is to present the technique, indications and results of translaminar screw fixation in the lumbar spine.Between 1987 to 1990, a total of 173 patients (81 male and 94 female) with a mean age of 53 (22-87) years underwent translaminar lumbar fusion.Surgery was performed using 45-mm ao screw and a 3.2mm ao drill bit.The average follow-up was 58 (42-71) months.The following complications were reported as follows: 7 patients died.The following are the clinical results of translaminar screw fixation according to number of levels fused: fair results in 23 levels at single-level fusion, 20 levels at two-level fusion, and 1 level at three-level fusion; poor results in 13 levels at single-level fusion, 7 levels at two-level fusion, and 1 level at three-level fusion.The following are the clinical results by indication: fair results in 8 patients with spinal stenosis, 7 patients with herniated discs, 10 patients with reintervention, 2 patients with degenerative changes, 4 patients with lumbosacral anomalies, and 1 patient with traumatic/post-traumatic changes; poor results in 5 patients with spinal stenosis, 2 patients with herniated discs, 7 patients with reintervention, 3 patients with degenerative changes, 2 patients with lumbosacral anomalies, and 1 patient with traumatic/post-traumatic changes.5 patients had radiolucent area around the screws.33 patients are taking analgesics because of lumbar back pain.10 patients (6%) or ten segments (4%) had non-union.8 patients had reoperation for painful pseudarthrosis; translaminar screws were removed and replaced by a transpedicular fixation and augmentation of the bone graft.1 patient had an l4/5 discitis after nucleotomy and screw fixation, which required operative drainage with removal of the screws.1 patient experienced persisting weakness of the quadriceps muscle after fusion and decompression in l2/3.1 patient suffered temporary paresis of the long thoracic nerve, probably due to positioning during surgery.3 patients had painful transient root irritation without objective neurological signs.In none of these cases was removal of the screws necessary, as no conflict of the screws with the involved nerve roots could be detected on postoperative myelograms.2 patients had to undergo wound revision after 12 and 15 days respectively, due to secondary wound healing.In 1 patient a wrong level was fused, which had to be reoperated, with a good final outcome.2 patients had deep vein thromboses, which required prolonged bedrest and intravenous anticoagulation.1 patient had postoperative pneumonia.7 patients had urinary tract infections, which were successfully treated with antibiotics.1 patient with segmental dysfunction had pseudarthrosis and was reoperated successfully by posterior transpedicular fixation technique.1 patient with spinal stenosis required revisional surgery for further decompression and stabilization.2 patients with spinal stenosis had non-union indicated with a moderate back pain and refused further treatment.9 patients had degenerative spondylolisthesis, but no progression of deformity was observed.12 patients had degenerative scoliosis, but no progression of deformity was observed.In 21 patients, additional revision and decompression was considered necessary on the basis of the clinical symptoms.9 patients had only back pain, which was connected to the iatrogenic instability.2 patients who underwent revision surgery had pseudarthrosis, both requiring additional surgery with anterior interbody fusion.1 patient had dural tear which occurred during a decompressive procedure and was sutured without any further sequelae.2 screws were broken; however, no motion could be detected on the flexion/extension radiographs.This report is for an unknown synthes spinal screws.It captures the reported events of radiolucent area around the screws, lumbar back pain, non-union, reoperation for painful pseudarthrosis, l4/5 discitis, persisting weakness of the quadriceps muscle, temporary paresis, painful transient root irritation, undergo wound revision, wrong level fusion and reoperation, deep vein thromboses, urinary tract infection, pseudarthrosis, required revisional surgery, degenerative spondylolisthesis, degenerative scoliosis, additional revision and decompression was considered necessary, dural tear during decompression.This is report 1 of 4 for complaint (b)(4).

• 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: 9403523
• MDR Text Key: 185682766
• Report Number: 8030965-2019-70702
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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: 11/13/2019
• 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