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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS: USS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS: USS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Migration (4003)
Patient Problems Nerve Damage (1979); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative

510k: this report is for an unknown mono/polyaxial screw/unknown lot. Part and lot numbers 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. (b)(4).

 
Event Description

This report is being filed after the review of the following journal article: yun d. , et al (2018) salvage anterior lumbar interbody fusion for pseudoarthrosis after posterior or transforaminal lumbar interbody fusion: a review of 10 patients,world neurosurgery volume 111, pages e746-e755 (korea south) https://doi. Org/10. 1016/j. Wneu. 2017. 12. 155. This study aims to assess the usefulness of alif in salvage surgery to treat failed plif or tlif. Between december 2006 and december 2016, a total 10 patients who underwent lumbar interbody fusion through tlif or plif and who had symptomatic pseudoarthrosis, a history of previous cage removal, and underwent salvage surgery for alif were studied. Perimeter (medtronic, dublin, ireland); wsh (nhs co. Ltd. , seoul, korea); syncage & synfix (synthes gmbh, zuchwil, switzerland) were used. The average follow-up period was 24. 3 to 7. 57 months. The following complications were reported as follows: (patient no. 7) a case of a (b)(6) year old female had preoperative subsidence ; aortic calcification and pseudoarthrosis. (patient no. 8) a case of a (b)(6) year old male had preoperative subsidence; pseudoarthrosis. (patient no. 9) a case of a (b)(6) year old male on the plain radiographs and ct scans, 2 cages previously implanted in the l4-5 levels presented with posterior dislodgement. The right cage was compressing the l4 spinal nerve root. A periscrew halo was observed in the 2 screws inserted at l4. The screw inserted right into the s1 level passed through the right foramen of the s1 level and was suspected to be damaging the s1 spinal nerve root. Having posterior screw malposition and pseudoarthrosis of the interbody cage; aortic calcification. (patient no. 10) a case of a (b)(6) year old female (patient 10) had posterior screw malposition and pseudoarthrosis of the interbody cage, preoperative subsidence and aortic calcification. One cage was removed for this patient. Previous cage showed anterior dislodgement. On the plain radiographs and ct scans, it can be seen that the 2 cages previously inserted have subsidence. The cage was inserted into the right side and stuck to the posterior of the l4 vertebral body and to the front of the l5 vertebral body. The cage was inserted into the body up to half of the upper and lower vertebral bodies. The left cage had subsided but was not more severe than the right side. At the l4 level, the screw inserted into the right invaded disc space at the l3-4 levels. This is report 6 of 9 for (b)(4). This report is for an unknown synthes synfix and syncage.

 
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Brand NameUNK - MONO/POLYAXIAL SCREWS: USS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key10144698
MDR Text Key197102001
Report Number8030965-2020-04117
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 06/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/11/2020 Patient Sequence Number: 1
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