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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON FENESTRATED SCREW SET ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON FENESTRATED SCREW SET ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 55750025535
Device Problem Leak/Splash (1354)
Patient Problems Extravasation (1842); Unspecified Tissue Injury (4559)
Event Date 11/23/2020
Event Type  malfunction  
Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. 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 vertebra fracture. It was reported that intra-op, the cement leak out into screw head instead of coming out at fenestrated screw holes. The cement was leaked at the lateral part of the vertebra and the surgeons was able to remove it at the end of the surgery with an injury to the patient. Further there were no patient symptoms or complications as a result of this event. There were no injury to patient. Antibiotic and analgesics were prescribed to improve situation. There is no additional device used as a result of the event. There was a delay of 1hr 30 min as a result of the event.
 
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Brand NameCD HORIZON FENESTRATED SCREW SET
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 Key11292203
MDR Text Key230670897
Report Number1030489-2021-00154
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K201362
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number55750025535
Device Catalogue Number55750025535
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/08/2021 Patient Sequence Number: 1
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