MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG N/A; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	75445540
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).The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.X-ray review review: l2-s1 post-op films are provided.There has been a partial l4 vertebrectomy with fracture of the several pedicle screws.Fusion status is unknown.There appears to be a paucity of bone graft within the cage.The fit of the cage to the l3 and l5 endplates also appears poor, but there is not much subsidence, likely causes are failure of fusion.
Event or Problem Description
It was reported that patient underwent a l4 decompression procedure and underwent removal of pedicle due to syntripsis.On an unknown date, post-op,screws broke.Patient underwent revision surgery in which the screws were partially explanted.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Product analysis: visual review confirmed the implant is fractured between approximately 3 threads from the base of the bone screw head.Optical examination of adjacent surface around the possible area of crack propagation did not identify material surface defect that could contribute to crack propagation.Fracture surface severely damaged, likely due to repeated, cyclic impact of the upper and lower portions of the bone screw, post-fracture.Dimensional examination of the major and minor diameters confirmed conformance to print specification.Inconclusive; the extent and severity of the fracture surface damage renders the implant unsuitable for further analysis.
Additional Manufacturer Narrative
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.

• Brand Name: N/A
• 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: 6172754
• Report Number: 1030489-2016-03402
• Device Sequence Number: 464568
• Product Code: KWP
• UDI-Device Identifier: 00885074134017
• UDI-Public: 00885074134017
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2017

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: 75445540
• Device Lot Number: H09H2547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 01/30/2017
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 12/26/2016; 01/30/2017; 09/27/2017
• 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: 21 YR