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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number MSB_UNK_SCREW
Device Problem Break (1069)
Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)
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 medtronic representative regarding a patient implanted with a screw for a fusion surgery. It was reported that on an unknown date, the patient had undergone revision in 2017 to include c3-c7. At this time, all hardware originally by depuy with medtronic, was revised on 2018 to include c2 resulting in fusion from c2 to c7 using the medtronic vertrex titanium post spine screws. Post operative imaging showed text book placement and remodeling. Early 2019, the patient began to experienced severe pain in the area of c3. Imaging done in 2019 showed that the screw implanted at c3 was broken in half, which was identified during a consult within unknown date. There has been no trauma that would have resulted in damage to this hardware. There is also no trauma to the surrounding bone. The only viable failure modes are a fault in the material or a manufacturing defect. This complaint involves unknown number of devices. Procedure date was (b)(6) 2019. No further complications were reported/ anticipated.

 
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Brand NameUNKNOWN
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 Key11299278
MDR Text Key233270128
Report Number1030489-2021-00159
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMSB_UNK_SCREW
Device Catalogue NumberMSB_UNK_SCREW
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated By Manufacturer? No
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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