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

Catalog Number	7570955
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: four bone screws returned, and four set screws were returned.There is a major amount of wear on the saddles of the bone screws where it appears that the rod was moving back and forth.There are two noticeable wear lines from where it appears the set screws were retorqued but loosened again.The set screws all have witness marks on the outer edge of the screw face that is consistent with the edge of the screw contacting the rod during torquing of the screw.The node on the face of the set screw is deformed in an atypical manner than bench samples that have been fully torqued correctly.Both observations are consistent with the rod not being seated fully in the bone screw saddle and the set screw being used to reduce the rod.It is noted that there is wear on the face of the set screw also from the rod moving back and forth.X-ray review: single post-op x-ray demonstrates hardware failure at lumbo-sacral junction long segment instrumentation performed.Multiple surgeries listed in report complicated by infection.Deformity correction has not been achieved in the coronal plane.Root cause: patient specific factors.
Event or Problem Description
It was reported that on an unknown date, the set screws loosened and dislocated due to which a revision surgery was performed.It was reported that the l5 and s1 screws on both sides loosened on (b)(6) 2017.On (b)(6) 2017: wound infection and loosening of the set screw l5 and s1 left and s1 right side.On (b)(6) 2017: wound infection and loosening of the set screw l5 and s1 on both sides.On (b)(6) 2017: loosening of the set screw l5 and s1 on both sides, removal of the screws l5 and s1 and re-instrumentation of l5 and s1.The first loosening of a set screw at all recognized in a ct scan on (b)(6) 2016: screw l5 left consequently the bi-segmental instrumentation (l3-l5) was enlarged to l2-s1 on (b)(6) 2017.Then the postoperative ct scan showed a chance fracture of l 1 above the instrumentation whereupon the instrumentation was again enlarged up to t11 ((b)(6) 2017).In the further course the patient was discharged and was followed up in our outpatient clinic at the end of (b)(6) 2017.The l5 screws were implanted on (b)(6) 2016.The s1 screws were implanted on (b)(6) 2017.The screws were removed on (b)(6) 2017.

• 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: 7202959
• Report Number: 1030489-2018-00082
• Device Sequence Number: 16369916
• Product Code: KWP
• UDI-Device Identifier: 00885074457567
• UDI-Public: 00885074457567
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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: 7570955
• Device Lot Number: H5341164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 01/18/2018
• 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: Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 100