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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC X-STOP PEEK INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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MEDTRONIC SOFAMOR DANEK USA, INC X-STOP PEEK INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Catalog Number 1-3210
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Type of Reportable Event Serious Injury
Additional 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.
 
Event or Problem Description
Pre-op diagnosis: lumbar canal stenosis levels implanted: l4-l5 it was reported that on unknown date, post op, in the survey it was found that the zcq score of the patient had variations and the patient did not get effective pain relief.
 
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Brand Name
X-STOP PEEK INTERSPINOUS SPACER
Common Device Name
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key6613748
Report Number1030489-2017-01452
Device Sequence Number781395
Product Code NQO
UDI-Device Identifier00643169132832
UDI-Public00643169132832
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P040001
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source foreign,health professional,s
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/04/2012
Device Catalogue Number1-3210
Device Lot Number2232391
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/12/2017
Supplement Date Received by Manufacturer05/12/2017
Initial Report FDA Received Date06/06/2017
Supplement Report FDA Received Date09/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Weight72
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