MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7571260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
Procedure: intended procedure l3/4 anterior lumbar interbody fusion (alif) level implanted: t10-s1 pre-operative diagnosis: non-union of previous instrumented spinal fusion it was reported that post-op, the rod was broken.The breakage was identified during intra-op alif procedure.A revision surgery was performed to re-stabilise the previous posterior fixation construct.The product came in contact with the patient.No fragment remains in the patient.
Additional Manufacturer Narrative
Xray reviews: intra-op films for alif shows a previously placed posterior rod fracture, levels are unknown, time from initial surgery is unknown.Fusion status is unknown, but likely incomplete if a construct is being utilized.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): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8102534
• Report Number: 1030489-2018-01546
• Device Sequence Number: 1345908
• Product Code: KWP
• UDI-Device Identifier: 00613994303196
• UDI-Public: 00613994303196
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 7571260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 01/19/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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: 87 YR