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

Model Number 199721000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 Description

The following event was reported: both screwdriver part codes fail at the moment of blocking the expedium verse system, when reviewing the distal tip it is evidence that it deteriorated despite being a new instrument.At the moment of placing the double-pass bushes (code 199721000) with the screwdrivers, they are stolen.It tries to close, and the screwdrivers do not work with the torque handle 299704320.The surgeon wants to close and notices that the cap is damaged.Place another bushing and when you want to do the final torque the x25 inserter screwdriver piece does not block.The surgery was extended for approximately 5 hours.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Visual examination of the correction key found that the threads on the poly lock were torn.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 with the information provided, a definitive root cause for the torn threads on the verse correction key cannot be determined.Noted damage suggests that inadvertently cross threading of the poly lock occurred upon insertion into the tulip head.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: 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: 8557827
• MDR Text Key: 143393782
• Report Number: 1526439-2019-51575
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: (01)10705034466132
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 226150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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): Other