MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	55840008550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
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 was pre-operatively diagnosed with neuro stenosis and underwent lumbar spine fusion at l5-s1.During the surgery, the implant broke when surgeon tried to implant.Broken implants were removed and replaced with another implant.The products came in contact with the patient.No fragment remained in the patient.No patient symptoms or complication were reported as result of this event.
Additional Manufacturer Narrative
Product analysis: visual inspection confirms the bone screw disassembled from the head.The ring and crown were still assembled in the head.A portion of the ring has been sheared through the cross-sectional area, with the remaining portion of the ring still seated in the groove of the head.The retaining ring is fully seated but has been deformed and partially sheared off.The deformed and sheared areas are on either side of the retaining ring gap and would reduce the force required for head disassembly.The diameter of the bone screw head in the undamaged area was checked and meets print spec.The above observations are consistent with overload as the mechanism of failure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8118016
• Report Number: 1030489-2018-01586
• Device Sequence Number: 1569256
• Product Code: KWP
• UDI-Device Identifier: 00643169004412
• UDI-Public: 00643169004412
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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 Number: 55840008550
• Device Lot Number: H5248746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1