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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 2991026
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
(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we cannot determine definitive cause of event.
 
Event or Problem Description
It was reported that patient underwent transforaminal lumbar interbody fusion at l3/4/5 on (b)(6) 2014.On an unknown date, post-op, neurological symptom was observed as cages backed out due to unsuccessful bone union.Revision surgery is scheduled.
 
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Brand Name
CAPSTONE 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 Key6123603
Report Number1030489-2016-03221
Device Sequence Number10919382
Product Code MAX
UDI-Device Identifier00613994290991
UDI-Public00613994290991
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K073291
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
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 Expiration Date09/07/2019
Device Catalogue Number2991026
Device Lot NumberH11G2123
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 Date11/23/2016
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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