MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 7.0X45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199725745S

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #
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> (b)(4).Surgical intervention took place in the form of a revision surgery.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

It was reported, the primary surgery was performed on (b)(6) 2018 to fix l5-s1 by using 2 rods (p/n: 196789480, lot number were gm46538 and gm46535).After the primary surgery, the surgeon found (on unknown date) under x-ray that the rod inserted to left side of l5-s1 (p/n: 196789480, lot number was gm46538 or gm46535) was broken, and the screw (p/n:199725745s, inserted to left side of s1) was also broken and separated into two pieces.The revision surgery was performed on (b)(6) 2018 and was completed by revising the rods and the screw.The patient is under monitoring now.No further information was provided by the hospital.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Visual examination of the returned screw reveals signs of operative use as evidenced by superficial markings, with its threads completely peeled off and damage to the drive feature of the screw head.It was noted that tulip head of the screw was completely broken on one side and partially on the other side.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.With the information provided, a definitive root cause for the postoperative breaking of the screw cannot be determined.In general, patient factors that may affect the performance of the components include patient anatomy, bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto are unknown.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 CAN SCR 7.0X45
• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7977931
• MDR Text Key: 124101854
• Report Number: 1526439-2018-50985
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440934
• UDI-Public: (01)10705034440934
• 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,Followup,Followup
• Report Date: 09/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 199725745S
• Device Lot Number: 147919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 120