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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number UNK - MONO/POLYAXIAL SCREWS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Necrosis (1971); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 02/15/2019
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). This report is for an unknown - mono/ polyaxial screws/ unknown lot number. Without the specific part number, the udi number and 510k 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. 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: okuda, a. Et al. (2019), minimally invasive spinopelvic ¿crab-shaped fixation¿ for unstable pelvic ring fractures: technical note and 16 case series, journal of orthopaedic surgery and research, vol. 14(1), pages 1-7, (japan). The purpose of this study was to describe the surgical procedure for mis crab-shaped fixation and to report on clinical outcomes. Between 2010 to 2016, a total of 16 patients (8 males and 8 females) with an average age of 50 years (range, 19-82 years) underwent crab-shaped spinopelvic fixations using the open pedicle screw system (uss2 poly-axial system, synthes), subsequently changing to the percutaneous pedicle screw system (spirit pangea system, synthes). Currently, we use the new percutaneous pedicle screw system (matrix¿x-tab system, depuy-synthes, or creo-mis, globus). Among the 16 cases, we implanted 33 pedicle screws and 64 iliac screws. The following complications were reported as follows: (b)(6) year-old female patient had ssi (b)(6) but had bony union. (b)(6) year-old female patient had ssi (b)(6) and gluteal muscle necrosis, ssi (b)(6) but had bony union (in both cases, the infections were deep (b)(6). Treatment included debridement and negative pressure wound therapy (npwt), with one patient requiring removal of the distal implants (left and right iliac screws), with the proximal implants remaining in situ (both iliac screws and l5 pedicle screws). In the other case, gluteal necrosis developed after transcatheter arterial embolization (tae), which resulted in deep infection. The patient was treated with debridement and npwt without the removal of the implants. After bony union was achieved at 3 months, all implants were removed and the infection was cured. ) (b)(6) year-old male patient had lt l5 nerve root pain remained. Re-operation performed. He had bony union (b)(6) year-old male who sustained an unstable ao type c2 pelvic ring fracture in a traffic accident, including a bilateral fracture of the denis zone ii of the sacrum and a 15-mm vertical dislocation (cranial direction). Preoperative three-dimensional computed tomography showing the h-shaped sacral fracture. The 15-mm vertical dislocation (cranial direction) is observable on the preoperative coronal plane. Postoperative radiographs, showing the crab-shaped fixation. Postoperative ct showing a residual 7. 5-mm vertical dislocation (cranial direction). We reduced the vertical displacement from 15mm to 7. 5mm, but the patient complained of pain caused by l5 nerve root entrapment. Radiculography of the l5 nerve root, using a contrast agent, confirmed impingement of the nerve root, shown by the black arrow in fig. 3, with stimulation of the nerve root reproducing the patient¿s pain. As the residual vertical displacement of the fracture was compressing the nerve root, we proceeded with a repeat reduction of the fracture, successfully decreasing the residual displacement to 5 mm, with resolution of the neurological symptoms 8 presented with a vertical displacement = 10mm. The average reduction length was 7. 0 mm (range, 5. 4 to 9. 0 mm), with an average reduction of the vertical displacement of 48% (range, 34% to 52%) among the 8 cases with vertical displacement, a residual displacement of = 10mm was identified in only 1 case, with no associated neurological symptoms from the lumbosacral plexus. This report is for an open pedicle screw system (uss2 poly-axial system, synthes), a percutaneous pedicle screw system (spirit pangea system, synthes) and a percutaneous pedicle screw system (matrix¿x-tab system, depuy-synthes). This impacted product captures the reported removal of the distal implants (left and right iliac screws). This report is 6 of 6 for (b)(4).

 
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Brand NameUNK - MONO/POLYAXIAL SCREWS
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9941673
MDR Text Key196582393
Report Number8030965-2020-02749
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 03/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK - MONO/POLYAXIAL SCREWS
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 Received03/12/2020
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: 04/08/2020 Patient Sequence Number: 1
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