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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 5011222
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Nerve Damage (1979)
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.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Pre-operative diagnosis for this procedure: spinal canal stenosis procedure or technique used: posterior lumbar interbody fusion levels implanted: l4-5 it was reported that post-op, cage at l4-5 backed out.Patient had nerve root symptoms attributed to cage back out.
 
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Brand Name
CAPSTONE CONTROL 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 Key8367929
Report Number1030489-2019-00199
Device Sequence Number1734058
Product Code MAX
UDI-Device Identifier00643169677524
UDI-Public00643169677524
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K171107
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/25/2019
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 Number5011222
Device Lot NumberH5395197
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2019
Initial Report FDA Received Date02/25/2019
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;
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