MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Paralysis (1997); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown uss construct/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.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: ivanic gm et al.(2007), mid-term outcome after fusion due to isthmic spondylolysis, wiener medizinische wochenschrift, volume 157, page 16-20, ((b)(6)).The aim of the present study was to measure the success of treatment after a sufficiently long period of time.Between january 1, 1997 and december 31, 2000, 77 patients who underwent surgery for isthmic spondylolisthesis of the lumbar spine were included in the study.There were 41 women and 36 men with an average age of 35 years (range, 17-56 years).Fifty-eight (58) patients underwent fusion by anterior lumbar interbody fusion (alif) and dorsal spondylodesis, of which 27 patients underwent transperitoneal and 31 patients extraperitoneal surgery from a ventral direction.Alternatively, 19 patients were fused by dorsal spondylodesis and posterior lumbar interbody fusion (plif) after laminectomy.Until 1998, a competitor¿s device was used for dorsal spondylodesis, thereafter the unknown synthes universal spine system titanium instruments for dorsal instrumentation.A competitor¿s cages were used on implants for the alif until 1998, followed by the unknown synthes syncage titanium cages and unknown synthes contact fusion cages titanium cage for the plif.At least five years postoperatively, all patients who could still be reached were recalled and examined clinically, radiologically and by questionnaire.Average follow-up period was 75 months (range 58-105 months) after surgery.The authors did not specify which patients received the synthes devices.Thus, complications will be reported as follows: 2 patients had peritoneal nerve paralysis.1 patient had dura injury (treated intraoperatively - no further problems).2 patients had superficial wound healing disorders.2 male patients had retrograde ejaculation disorders (both healed without consequences).2 patients had paralytic ileus (treated conservatively) occurred.This report is for the unknown synthes universal spine system titanium, unknown synthes syncage titanium cages, and unknown synthes contact fusion cages titanium cage.A copy of the literature article is being submitted with this medwatch.This is report 1 of 6 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: USS
• 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: 10816173
• MDR Text Key: 217445386
• Report Number: 8030965-2020-08788
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 10/15/2020
• 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