MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 8X40; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727840
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent 1st surgery on (b)(6) 2018, fusion l5-s1 with expedium and t-pal.On (b)(6) 2018, revision surgery because of radiculopathy and suspicion on infection.Implants where loose, have been removed and replaced.Post op pain free.Tissue has been examined in bacteriology, one sample was positive.Patient showed up in (b)(6) with back pain, examinations have shown again pseudarthrosis and loosening of the implants.On (b)(6), again revision surgery, removal of all implants, which have been sent in for bacteriological examination.Several tissue samples will also be examined bacteriologically.T-pal cage will be removed from anterior after these results of the bacteriological examination are known.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).Back pain.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The screw features signs of use such as surface markings and discoloration.However, the screw featured no signs of loosening.No postoperative x-rays were provided to confirm the pedicle screw loosening.The loosening cannot be replicated.With the limited information, the report of the screw loosening cannot be confirmed.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The root cause of the poly screw loosening postoperatively cannot be determined from the sample and information provided.A potential root cause cannot be determined since the report of the screw loosening could not be confirmed or replicated.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MIS TI CFX FEN POLY 8X40
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8621158
• Report Number: 1526439-2019-51655
• Device Sequence Number: 10836905
• Product Code: PML
• UDI-Device Identifier: 10705034282770
• UDI-Public: (01)10705034282770
• Combination Product (Y/N): N
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/29/2019

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 Model Number: 186727840
• Device Catalogue Number: 186727840
• Device Lot Number: 192622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 06/04/2019; 06/04/2019; 07/17/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 05/20/2019; 06/21/2019; 06/21/2019; 07/18/2019
• 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: 64 YR
• Patient Weight: 57