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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 2991626
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/05/2020
Type of Reportable Event Malfunction
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
It was reported that the patient underwent transforaminal lumbar interbody fusion (tlif) at l4-l5 due to degenerative disc disease.Intra-op, the spacer broke.No any fragments of the implant remaining in the patient body.There were no any complications associated with patient due to this event.
 
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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 Key9792148
Report Number1030489-2020-00258
Device Sequence Number16747101
Product Code MAX
UDI-Device Identifier00613994290878
UDI-Public00613994290878
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K073291
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number2991626
Device Lot NumberH5483067
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2020
Initial Report FDA Received Date03/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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