MAUDE Adverse Event Report: MSD DEGGENDORF MFG CAPSTONE CONTROL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4001522
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not 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 on an unknown date, post-op, spacer ejected/migrated at l5-s1.Spacer progressively dislodged posteriorly beginning less than 1 month from the initial surgery.Radiographically identified 4-5mm of posterior movement compared with immediate pos t-operative films on (b)(6).As a result, patient underwent revision anterior surgery.Dislodged cage was successfully removed from the anterior approach and the l5-s1 level was re-implanted with a an interbody spacer and plate.Patient is currently stabilized and recovering well following revision surgery.
Additional Manufacturer Narrative
Product analysis- visual and microscopic examination were performed on the returned spacer.The spacer was returned not broken.A visual analysis reveals heavy damage to the nose of the implant but this may have occurred during the removal process.At this time there does not appear to be a failure of the spacer.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 7040856
• Report Number: 1030489-2017-02357
• Device Sequence Number: 2037130
• Product Code: MAX
• UDI-Device Identifier: 00643169109582
• UDI-Public: 00643169109582
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K120368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2018

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: 4001522
• Device Lot Number: 0008891185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 03/30/2018
• 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: 69 YR
• Patient Weight: 91