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

Catalog Number	4001427
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2013, the patient suffered from a condition in his lower back which required stabilization of his spine.As a result of patient's medical condition, doctor installed hardware into his back which included titanium screws.Post-op, on (b)(6) 2014 (date is approx.), two of the titanium screws broke causing the hardware installed to become loose and destabilize the spine and pain to the patient.Allegedly, the patient underwent revision surgery for installation of new hardware and titanium screws.

• 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: 6379649
• Report Number: 1030489-2017-00460
• Device Sequence Number: 16312641
• Product Code: MAX
• UDI-Device Identifier: 00643169109827
• UDI-Public: 00643169109827
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K120368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2017

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 Date: 08/27/2020
• Device Catalogue Number: 4001427
• Device Lot Number: WF46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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