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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG MULTI-AXIAL SCREW FOR 4.75MM ROD ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG MULTI-AXIAL SCREW FOR 4.75MM ROD ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 54740005530
Device Problem Break (1069)
Patient Problems Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)
Event Date 12/17/2019
Event Type  Malfunction  
Manufacturer Narrative

Pma/510(k): no. For similar product marketed in us is k091974. Product is not returned at the time of this report. Analysis report will be attached to supplemental report once product is received back and analysed. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of th12 vertebral body fracture. It was predicted that the fusion had not achieved after plf (revision surgery) which was performed on (b)(6) 2019 and screw breakage had occurred. The patient had recovered for a while, but symptom relapses and the patient has become difficult to walk now. For the paralysis due to the kyphosis after surgery performed at th12 and posterior movement of the bone fragment, posterior decompression and instrumentation and bone graft had been performed, but one screw on the left side of l1 broke, the fixing force was lost. There were fragments left in the patient. Health damage in patient is reported. After the operation, the screw broke. The re-operation was performed on (b)(6), 2020 (imp of non-medtronic was placed from anterior side). It has not decided to replace the screw that used for posterior spinal fusion, so the screw was not planned to be returned. The re-operation was completed on (b)(6) by posterior instrumentation from th8 to l1 and iliac bone graft on th10/11/12 of the pseudo joint. The broken screw was removed without leaving any fragment in the patient's body, and all other screws were replaced because they were found to be loose.

 
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Brand NameMULTI-AXIAL SCREW FOR 4.75MM ROD
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10300879
MDR Text Key199713679
Report Number1030489-2020-00941
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
PMA/PMN NumberSEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number54740005530
Device Catalogue Number54740005530
Device LOT NumberH5517992
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/13/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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