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 07/06/2018

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

It was reported that spinal fixation or spondy grade 2 s1-l5 was performed.6 months after surgery the treating physician noticed that one screw (right side) was broken, and the rod had slipped through the screw head in s1 on left side.Right side the screw was broken and had rotated.Also the rod had slipped through the screw head l5 on this side.All locking caps were tightened according to the surgical technique and double checked during surgery for correct torque locking.The rod slippage and breakage has occurred in the months after the surgery.The surgery itself was successful and no postoperative events have occurred that might explain the screw breakage.The patient was treated for a spondy grade 2 at level s1-l5.Primary surgery date (b)(6) 2017.Patient's gender female.Dob (b)(6).No other patient data is available.

Manufacturer Narrative

(b)(4).Visual examination of the setscrew revealed signs of operative use as evidence by superficial markings, with threads and drive feature slightly worn.It was noted that the rod striations were observed on the set screw suggesting that the set screw were seated properly.A functional analysis was performed.It was noted the set screw could easily be threaded into the screw head.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.A functional analysis was performed with a poly-axial screw and x25 inserter from which it was noted the set screw could easily threaded into the screw head.Additionally, rod striations were observed on the set screw suggesting that the set screw were seated properly.The investigation could not verify or identify any evidence of the device contribution to the reported problem.It is not suspected that the device failed to meet specifications.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 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 INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 8117223
• MDR Text Key: 128876430
• Report Number: 1526439-2018-51109
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 199721001S
• Device Lot Number: TF1323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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