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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RODS: TROLLY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RODS: TROLLY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Patient identifier: (b)(4). This report is for an unknown rods: trolly/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. (b)(4). Device was used for treatment, not diagnosis.

 
Event Description

Device report from synthes reports an event in (b)(6) as follows: it is was reported that on an unknown date, that significant progression of the spine deformity was noted on the 5 year control (68° right thoracic curve), with the decision taken to perform trolley implants removal and definitive spine fusion. Surgery has currently been scheduled for (b)(6) 2020. Concomitant devices reported: trolley screws (part number unknown, lot unknown, quantity 1). This report involves unknown rods: trolly. This is report 2 of 2 for (b)(4).

 
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Brand NameUNK - RODS: TROLLY
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
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10626437
MDR Text Key209787540
Report Number8030965-2020-07697
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 09/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
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: 10/05/2020 Patient Sequence Number: 1
Treatment
UNK - TROLLEY SCREWS
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