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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 7068396
Device Problems Break (1069); Flaked (1246)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
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. This part is not approved for use in the(b)(6) united states; however a like device catalog # 5440030, 510k # k102555 and udi # (b)(6) was cleared in the united states. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis- palindromia hernia involved in the reported event. Levels treated/implanted- l3/4. It was reported that intra-operatively, when fitting the break off set screw, it was scraped, and fragment came out. Product broke and no fragments left in the patient's body. No additional surgery performed as a result of this event. There were no patient symptoms reported. There were no further complications reported regarding the event. Event was revision surgery, and no implants were used.
 
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Brand NameCD HORIZON SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key13023633
MDR Text Key288797400
Report Number1030489-2021-01558
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7068396
Device Catalogue Number7068396
Device Lot NumberH5687717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/16/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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