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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 3992209
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes Neurological Deficit/Dysfunction (1982); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It is unknown which of the devices backed out among the ones used having lots as follows: h5233176 and/ or h5265385.(b)(4).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
 
Event or Problem Description
It was reported that on an unknown date, post-op, cage at l4/5 backed-out slightly above the posterior wall.The cage caused neurological symptom.Revision surgery was performed.
 
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Brand Name
CAPSTONE PTC SPINAL SYSTEM
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
MDR Report Key6128392
Report Number1030489-2016-03269
Device Sequence Number13735503
Product Code MAX
UDI-Device Identifier00643169187542
UDI-Public00643169187542
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133205
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/04/2016
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? Yes
Operator of Device Health Professional
Device Catalogue Number3992209
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/04/2016
Initial Report FDA Received Date11/28/2016
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; Required Intervention;
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