MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER T27 ILIAC SCREW 8X90, TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179706890
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 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 on (b)(6) 2019, patient underwent revision surgery.Patient hat initial th10-s2 spinal fusion surgery in (b)(6) 2019 with two cages (globus altera) at l4/5 and l5/s1) and expedium verse classic screws at level and a s2 viper t27 riliac screws at level s2 (8x90mm).Rod slippage at level s2 in viper t27 revision screws app.2 months after initial surgery.Revision surgery hat to be done in june 2019.During revision surgery, the surgeon noticed that both innies of the s2 viper t27 iliac screws were totally loose.Furthermore, screw loosening was observed at several levels including s2.Surgeon decided to replace all screws with new ones (expedium verse advanced and 9mm viper t27 revision screws).Surgical delay is unknown.Procedure and patient outcome is unknown.This complaint involves four (4) devices.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Udi: (b)(4).Upon visual inspection of the returned device, it was observed that the connection between the head and the shaft of the screw was loosened.There was foreign material inside the screw shaft.No other issues were identified with the returned components of the device.The complaint condition is confirmed for the screw as the device was loose.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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: VIPER T27 ILIAC SCREW 8X90, TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8798557
• Report Number: 1526439-2019-51840
• Device Sequence Number: 11472921
• Product Code: NKB
• UDI-Device Identifier: 10705034266466
• UDI-Public: (01)10705034266466
• Combination Product (Y/N): N
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 179706890
• Device Catalogue Number: 179706890
• Device Lot Number: TBUWP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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