MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Not Applicable (3189)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the returned device found the thread on the device peeling and discoloration was observed.Rest of the device showed no signs of damage.A review of the device history record could not be performed as the part number/lot number combination could not be found.The complaint condition was confirmed as the threads of verse correction key were peeling, which could have contributed to the complaint condition.There was no indication that a design or manufacturing issue has caused the peeled threads and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.

Event Description

After the first final tightening of the correction cap screws with the torque, after 20 op - minutes it came to a decrease of the potentials in the neuromonitoring so that the correction had to be taken back.It was no longer possible to loosen the screw heads of the screws listed above - cold welding.The implants had to be removed and replaced by new ones.All correction cap screws had to be loosened and replaced.The insertion of these was difficult because the correction cap screws skipped threads when inserted into the screw head.Diagnosis: right convex thoracic scoliosis.The surgery delayed for about 60 minutes.The surgery finished successfully.

• Brand Name: VERSE CORRECTION KEY
• 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: 9290272
• MDR Text Key: 179792385
• Report Number: 1526439-2019-52367
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: 10705034466132
• 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: Other
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721000
• Device Lot Number: 245767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 17 YR