MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	3992209
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
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
It was reported that the patient was pre-operatively diagnosed with l5 spondylolysis; and underwent l5-s1 posterior lumbar interbody fusion and l4-s1 percutaneous pedicle screw fixation.The cage was inserted after curetting the intervertebral disc.The cage could only be inserted very close to the posterior wall.The physician checked if additional curetting was needed on the anterior side but found the cage's position to be good enough.Then insertion of cage was performed on the contralateral side.When inserting the cage on the contralateral side, the cage that was inserted before came out.The physician hammered the cage again.Then pps and compression was performed.Although it was suspected that the cage backed out a little when checking the sagittal images, the physician judged it was okay and the operation was completed.In the post-operative ct, the cage was found backed-out.Hence, the wound was re-opened and revision surgery was performed to remove the cage.After removing the cage, bone graft was filled there and operation was completed again.There was a delay of more than 60 minutes in overall procedure time as a result of this event.No patient complications were reported after the revision surgery.

• 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 Key: 8615192
• Report Number: 1030489-2019-00550
• Device Sequence Number: 19422896
• Product Code: MAX
• UDI-Device Identifier: 00643169187542
• UDI-Public: 00643169187542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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 Number: 3992209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR