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

Catalog Number	1556000500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) (intervention required) product was not returned to the manufacturer for evaluation.However, x-ray images were provided which were reviewed and the result is given below: image review: post op x-rays from t10- s1 fusion demonstrates rod fracture at l3-4 unilaterally.Fusion status is unknown.Instrumentation and lumbar lordosis otherwise appears appropriate.Root cause: indeterminate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, on (b)(6) 2016, patient was pre-operatively diagnosed with spinal stenosis and underwent posterior instrumentation, decompression, alif (anterior lumbar interbody fusion) at l1-iliac.On an unknown date, post-op, the rod broke.New operation is being planned.No patient complications were reported as the result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TSRH SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6728995
• Report Number: 1030489-2017-01799
• Device Sequence Number: 19023112
• Product Code: KWP
• UDI-Device Identifier: 00613994789914
• UDI-Public: 00613994789914
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K111942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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 Catalogue Number: 1556000500
• Device Lot Number: 0326750W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 09/11/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 65