MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TECHTONIX PLATE 22 - 34 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48202234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	06/15/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; there is a patient complaint and requested us to contact with the patient.Patient (b)(6) is contacted by (b)(4) manager and area manager (b)(4) and the following information is received; patient had the first surgery in 2012 plates.The reason of the first surgery was disc degeneration & stenosis.He had a short operation with local anesthesia in 2013 because of his pains, in 2015, he needed to have another surgery.The surgery took 4.5 hours and the doctor informed the patient that they opened him but could not do anything because they couldn't get the implants out.He tried to remove the implants with other instrument set, but could not manage.Doctor also told to the patient that, they tried to reach the distributor and the distributor told that these products were out of market.(distribution agreement was terminated by dec 2012.) implants in the patient were damaged during this surgery.Doctor also told the patient that, even if he can find the instruments, he can't perform the surgery.Patient's 3rd surgery was done and surgeon only could loosened his nerves.The patient is suffering now and the surgeons told him that he can't bear the 4th surgery, if he has the surgery, he would become paralysed.Patient told that he is suffering a lot, he lost his job and can't work since 7 months.He also stated that he is using prescribed drugs for his situation.Patient will have another mri and ct on friday (b)(6).The patient agreed to send his medical records after his checks on (b)(6).
Additional Manufacturer Narrative
Method: risk assessment; result: device history review could not be performed as no lot code was provided.Device evaluation could not be performed as no items were returned.Complaint history review could not be performed as no lot code was provided.Conclusion: the exact root cause could not be determined because the devices were not returned for evaluation.
Event or Problem Description
It was reported that; there is a patient complaint and requested us to contact with the patient.Patient (b)(6) is contacted by raqa manager and area manager turkey and the following information is received; patient had the first surgery in 2012 plates.The reason of the first surgery was disc degeneration & stenosis.He had a short operation with local anesthesia in 2013 because of his pains, in 2015, he needed to have another surgery.The surgery took 4.5 hours and the doctor informed the patient that they opened him but could not do anything because they couldn¿t get the implants out.He tried to remove the implants with other instrument set, but could not manage.Doctor also told to the patient that, they tried to reach the distributor and the distributor told that these products were out of market.( distribution agreement was terminated by dec 2012.) implants in the patient were damaged during this surgery.Doctor also told the patient that, even if he can find the instruments, he can¿t perform the surgery.Patient¿s 3rd surgery was done and surgeon only could loosened his nerves.The patient is suffering now and the surgeons told him that he can¿t bear the 4th surgery, if he has the surgery, he would become paralysed.Patient told that he is suffering a lot, he lost his job and can¿t work since 7 months.He also stated that he is using prescribed drugs for his situation.Patient will have another mri and ct on (b)(6).The patient agreed to send his medical records after his checks on (b)(6).

• Brand Name: TECHTONIX PLATE 22 - 34 MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6052680
• Report Number: 0009617544-2016-00421
• Device Sequence Number: 16384338
• Product Code: KWP
• UDI-Device Identifier: 04546540443144
• UDI-Public: (01)04546540443144
• Combination Product (Y/N): N
• PMA/510(K) Number: K050189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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: No Information
• Device Catalogue Number: 48202234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2016
• Supplement Report FDA Received Date: 01/13/2017
• 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