MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721001S

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2019, the following procedures for spinal fixation were successfully performed without surgical delay.Tlif (transforaminal interbody lumbar fusion) on l4/5.Plif (posterior lumbar interbody fusion) on l5/s.On (b)(6) a revision was performed for removing the blood tumor by detaching a cross-link device and replacing with a new one.But the surgeon left the final screw fixation as it was done in the original surgery.Postoperative x-rays did not show any adverse issue.On (b)(6), x-rays showed that the reported set screw (1997.21.001s) on the left l4 had been loose.A rod was about to come off the screw head.Any further revision is not planned as of today.No further information is available.Unknown rod (part # unknown, lot# unknown, quantity 1).This complaint involves one (1) device.

• Brand Name: 5.5 EXP VERSE UNITIZED SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8823045
• MDR Text Key: 152086666
• Report Number: 1526439-2019-51877
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466149
• UDI-Public: (01)10705034466149
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721001S
• Device Lot Number: OM10106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention