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

Catalog Number 199721000S

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  Injury  

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 Description

The following was reported: mr (b)(6) had an ais patient: (b)(6) female.Screws went in beautifully.He used verse top and bottom and uniplanar at the apex as lumbar curve on concavity.Used a cocr rod to correct on concavity.He put a ck in at top and bottom.The second most distal screw seemed to cross thread as he inserted which resulted in damaging the inside of the tulip.During the reduction.The tabs could not withstand the force applied and resulted in cross threading.This resulted in frustration caused as he replaced with a unitised.The unitised would not seat in the head of the screw either.The quick stick was applied.He left this locking cap and reduced the uniplanar screws and corrected the deformity.Once this has been done the rod was fully seated and he tried to put another unitised into the tulip.I suggested to take the extended tabs off and use the verse clip on reducer.He did this and the unitised failed to seat.He decided to leave the screw without a nut.

Manufacturer Narrative

Product complaint #
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> (b)(4).The expedium verse dual innie set screw was returned to the complaint handling unit for evaluation.It was noted that large sections of the set screw¿s threads have been torn from the body of the set screw.The damage to the threads is similar across the entire set screw, leaving behind the same type of markings wherever the damage may have occurred.The controlled manner of the damage is indicative of the set screw being tightened into a pedicle screw while cross threaded.Tightening the set screw while it is cross threaded can lead to stress building up on the thread, resulting in part of the thread splitting off from the body of the set screw.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the damage to the threads of the set screw cannot be determined from the sample and the information provided.A potential root cause may be inadvertently cross threading the set screw during insertion and tightening.This would place stress on the threads of the set screw, potentially resulting in them becoming damaged or torn.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 and no systemic trends were found, 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: 5.5 EXP VERSE DI 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: 8515492
• MDR Text Key: 141974298
• Report Number: 1526439-2019-51538
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466125
• UDI-Public: (01)10705034466125
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721000S
• Device Lot Number: 199793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1