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 Unspecified Infection (1930); Irritation (1941); Nerve Damage (1979); Weakness (2145); Hypoesthesia (2352); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes universal spine system/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: collados-maestre i, et al (2016).Transdiscal screw versus pedicle screw fixation for high-grade l5-s1 isthmic spondylolisthesis in patients younger than 60 years: a case¿control study.European spine journal.Volume 25.Page 1806-1812.(spain).The objective of this study was to compare functional and radiographic outcomes between transdiscal and pedicle fixation in patients younger than 60 years with high-grade l5-s1 isthmic spondylolisthesis.Between january 2007 and december 2012, patients with spondylolisthesis who underwent surgery with l5-s1 transdical fixation were clinically and radiographically compared to patients who underwent conventional pedicle fixation.The study included 25 patients (7 males, 18 females, mean age of 36.7 years) who underwent transdical fixation, and 31 patients (15 males, 16 females, mean age of 42.0 years) who underwent pedicle fixation.A routine posterior midline approach was used in both groups.A partial reduction was only performed in those patients who had severe spinopelvic sagittal imbalance.Standard titanium screw systems were used in all patients which included an unknown synthes universal spine system and other competitors¿ device.The standardized prospective assessment was made pre- and postoperatively at 3, 6, 12, and at least 24 months after surgery.Primary outcome measure in this study was the oswestry disability index (odi) score from 0 to 100 points, with lower scores indicating less severe symptoms.Clinical assessment was also performed in each visit by the core outcomes measures index (comi) ranged from 0 to 10 points, with lower scores indicating a better outcome.And sf-12 questionnaire which included physical and mental components with a 0¿100 scale with higher scores indicating a better quality of life.Pain at the lower back and the leg were each measured separately with a visual analog scale (vas) from 0 (no pain) to 10 (maximal pain).The mean postoperative follow-up was 2.6 years (range 2.0¿4.9) in the transdiscal group and 2.9 years (range 2.0¿5.3) in the pedicle group.The authors did not specify which of the patients were implanted with a synthes device.Thus, complications will be reported as follows: (transdical group)- 2 patients were unable to recover from previous leg weakness.2 patients were unable to recover from the sensorial deficit.2 patients developed transitory l5 root irritation after surgery.2 patients developed deep wound infection that was treated with debridement and final moderate functional outcome (odi = 32 and 44, respectively).1 patient with previous urinary incontinence, from which she recovered, had developed l4 partial neurologic deficit.A broken rod was also observed but solid fusion was achieved at 1 year after surgery, resulting in moderate disability.1 patient had breakage of a sacral screw that was observed at 3 postoperative years, although solid fusion was achieved a revision was not required.3 patients had a poor orientation of the sacral screws.1 of these patients was severely symptomatic due to a sacral screw misplacement that produced l5 radiculopathy, and this screw was subsequently removed, with the moderate final result (odi = 42).2 of these patients had fusion consequences and good functional results which included a (b)(6) year-old female patient who had transdiscal screws misplacement that was shown on a lateral x-ray taken 3 years postoperatively.There was nonprogressive slippage and the patient was asymptomatic.(fig.2) (pedicle group)- 2 patients were unable to recover from previous leg weakness.3 patients developed l5 partial neurologic deficit after surgery.1 patient had a dural tear which was repaired intraoperatively without residual sequelae (odi = 20).2 patients developed superficial wound infections (odi = 8 and 32, respectively).3 patients had pseudoarthrosis which required surgical revision to transdiscal fixation with successful final outcomes.1 patient had breakage of both sacral and lumbar screws due to pseudoarthrosis, with poor functional outcome (odi = 60).The patient was revised to transdiscal fixation with successful final outcomes.This report captures adverse events of leg weakness, sensorial deficit, l5 root irritation, deep wound infection with debridement, surgical intervention, pseudarthrosis (nonunion) and dural tear repaired.This report is for an unknown synthes universal spine system.This is report 1 of 5 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: 8509534
• MDR Text Key: 141773431
• Report Number: 8030965-2019-62748
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• 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: 03/21/2019
• 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