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 199721001

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Local Reaction (2035); No Code Available (3191)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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 the patient underwent multiple previous surgeries, the last one on (b)(6) 2017, l1 ¿ s1.During revision surgery on (b)(6) 2019, it was observed, that one screw was broken (could not be retrieved) and at least 4 inner set screws where loose, 2 of them were found beside the construct in the soft tissue.The result was heavy metallosis, pseudarthrosis in 2 levels and sclerosis in the levels with loose inner set screws.The following material was removed: expedium verse advanced- 3x 6mm; 3x 7mm; 5x 8mm; 12 inner set screws; 2 pieces of 279762480.

Manufacturer Narrative

Product complaint #
=
> (b)(4).(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Udi: ((b)(4).Lot numbers tn1232, tf1232, tn1333, tj1222, tf1321 were provided.It is unknown which lot was the complained device.Visual examination of the returned set screws feature little in the way of markings to its surface.However, the marks on the bases of these set screws vary.A review of the device history record was conducted for each lot.No issues were identified during the manufacturing and release of these products that could have contributed to the problem reported by the customer.The root cause of the set screws being loose cannot be determined from the samples and the information provided.A potential root cause cannot be readily determined due to the lack of identification of which set screws loosened.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: 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 INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8455371
• MDR Text Key: 139975586
• Report Number: 1526439-2019-51486
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Public: (01)UNAVAILABLE
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2019
• 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 Outcome(s): Required Intervention