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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
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OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR Back to Search Results
Device Problems Entrapment of Device (1212); Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 08/18/2006
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis.This report is for an unk - cage/spacers/unknown lot.Part and lot number are unknown; udi 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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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: lange, u.Et al (2006), titanium vertebral body replacement of adjustable size, unfallchirurg, vol.109, pages 733-742 (germany).The aim of the study was the prospective recording and analysis of the course of treatment with clinical and radiological outcome of the first 50 patients treated with synex.Between february 1999 to may 2000, a total 50 patients (29 male and 21 female) with an average mean age of 43.1 years (range 20-77 years) were included in this study.They treated 36 patients with fresh (=3 weeks) and 2 patients with older fractures (>3 weeks) of the thoracic and lumbar spine.The most frequent causes of accidents were falls from great heights (16/38) and car accidents (10/38).Corrective surgery was performed on 8 patients with post-traumatic malpositioning.3 patients were operated on for tumors, and one patient for spondylodiscitis.Mean follow up of 12 and 20 months.The following complications were reported as follows: 1 patient had died 3 months postoperatively from the consequences of breast cancer.1 patient with metastatic hypernephroma th12 with tumor nephrectomy in the same anesthesia.1 patient had a pedicle screw malpositioned which was corrected.2 patients had revision surgeries due to deep wound infection which healed without consequences.A synex sank into the caudally adjacent vertebral body after intraoperative injury of the cover plate during mobilization (figure 2).A pedicle screw broke.This report is for a synex (synthes) and internal fixator (uss pedicle screws).This impacted product captures the following adverse events: a synex sank into the caudally adjacent vertebral body after intraoperative injury of the cover plate during mobilization (figure 2).This report is for one (1) unk - cage/spacers this is report 2 of 3 for (b)(4).
 
Event Description
This is report 2 of 5 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
 
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Type of Device
INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8584494
MDR Text Key144246091
Report Number8030965-2019-63551
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received05/14/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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