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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

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM Back to Search Results
Model Number 55840004550
Device Problems Material Erosion (1214); Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative

Product was not 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

It was reported that the patient presented with adult deformity with both coronal and saggital plane imbalance, multilevel spinal stenosis and l5 radiculopathy with weakness and neurogenic claudication. He underwent t11-pelvis fusion. On an unknown date, post-op, the saddle of the reported screw (that was implanted at right t12) was worn heavily. Two set screws were also found loosened and dislodged. Additionally, there was metallosis around the treated site and pseudoarthrosis at t11-t12 was also reported. Hence, the patient underwent a revision surgery, in which the alleged screw and other hardware were completely explanted and were replaced with new ones. Extension of fusion from t4 to t11 was also performed as a result of proximal junctional kyphosis and junctional failure of t11.

 
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Brand NameCD HORIZON SPINAL 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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10140741
MDR Text Key194771291
Report Number1030489-2020-00597
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113174
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number55840004550
Device Catalogue Number55840004550
Device LOT NumberH5401409
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/10/2020 Patient Sequence Number: 1
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