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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 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number MSB_UNK_SET SCREW
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare provider via manufacturing representative regarding patient with c6 fracture diffuse idiopathic skeletal hyperostosis (dish) suggested for spinal therapy. Event occurred intra-op. Procedure used was cervical posterior fusion, levels implanted c3/th2. It was reported that at set screw final tightening, screw stripped. There was delay of less than 60 mins. It was the operation with 12 units of screws, 2 units of crosslink being placed. Of these, about 8 set screws for screws and 4 set screws on both sides of the crosslink, stripping occurred at final tightening. It stripped from the first one, but there was only one driver, all were used with the same driver. Therefore, the final tightening was performed manually and completed. In addition, on the next day, the rod was replaced. The reason was that, originally there was paralysis on right body due to trauma, and paralysis spread to left body. Opll may have become a compression factor due to the correction, so the rod was replaced to re-bend. The progress is unknown. When the set screw that stripped at final tightening was removed, it was able to be removed without stripping. No patient symptoms or further complications reported. Device will be returned. Update; unknown whether the screwdriver itself stripped or not. No patient symptoms. Update; in the reoperation on (b)(6) 2020, the rod placed on (b)(6) 2020 was bent again and placed again. About the reason for paralysis, do not change the information "opll may have become a compression factor due to the correction. " reported in the first report. The current patient status is unknown. Update; after re-evaluating the reported event(no new information),it was found some plis need to be changed. As 2 crosslinks setscrews(2 setscrews for each) were complained, changed (b)(4) to crosslinks. Void (b)(4). Update; the setscrews were removed once in the revision surgery because the surgeon needed to re-bend rods. We do not have the information whether the setscrews were implanted again or new setscrews were used in the revision surgery. It was able to be removed without stripping: this suggests these setscrews might not be stripped because they were able to be removed without any problems. However, since we could not tell if the setscrews were really stripped or not because we had not obtained them, we consider the setscrews were stripped.
 
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Brand NameCD HORIZON SPINAL SYSTEM
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 Key10940052
MDR Text Key219374507
Report Number1030489-2020-01734
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNKNOWN
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 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMSB_UNK_SET SCREW
Device Catalogue NumberMSB_UNK_SET 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 Received11/11/2020
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 Initial

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