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U.S. Department of Health and Human Services

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

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MDT SOFAMOR DANEK PUERTO RICO MFG PROLOCK CROSSLINK ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number G9010001540
Device Problems Break (1069); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2021
Event Type  malfunction  
Manufacturer Narrative
The device 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
Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with an indication of lumbar spinal canal stenosis (l2/3). It was reported that after the final tightening, it was attempted to remove the crosslink to reinsert screw, but the gold screw of the crosslink fixed to the rod on the right side stripped and it could not remove the crosslink from the rod. The set screw of screw was removed, and the rod was removed together for dealing with it. After reinserting the screw, a new rod and crosslink were placed, and the procedure was completed without problems. There was device breakage and no fragments of the device remained in the patient's body. The device had contact with patient. Tlif was performed at the same level for lumbar spinal stenosis of l2 / 3. No patient symptoms or complications as a result of this event. No additional surgery or treatment performed as a result of this event. There was delay in overall procedure time less than 60 minutes. No in-patient hospitalization or prolongation of existing hospitalization necessary. No further complications were reported.
 
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Brand NamePROLOCK CROSSLINK
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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key11441387
MDR Text Key241731229
Report Number1030489-2021-00316
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG9010001540
Device Catalogue NumberG9010001540
Device Lot NumberH5658769
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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