MAUDE Adverse Event Report: SYNTHES MEZZOVICO 7.0MM TI MATRIX MONOAXIAL SCREW 55MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.633.755

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Fitting Problem (2183)

Patient Problems Failure of Implant (1924); Sedation (2368)

Event Date 01/14/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that all 6 screws has loosen in spite of using the torque limiter.On the left site the rod is slip out from the last screw cranial.On the right site the rod was minimal fixed on the last screw cranial.A second surgery of 120 minutes was necessary.This report is 4 of 14 for (b)(4).

Event Description

A review of the x-rays was completed: the post-operative x-rays (two views) and x-rays of implants after failure (two views) and the x-rays appear to match the complaint description of left rod slipping out of screw and right rod also appearing to have slipped compared to original position.It is difficult to comment with certainty on the status of the set screws by comparing the x-rays.

Event Description

Update: it was reported that the explanted matrix system was substituted with the uss fracture during the revision procedure.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: no non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.It is unknown when the devices loosened and slipped out of place.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: (b)(6).Product investigation summary: the above listed item(s) were sent for examination and forwarded to the manufacturing location in the us.A conducted visual inspection showed that all pedicle screws show signs of use.Both bars have on the outside diameter material deformations, which may have been caused by the tightening of the caps.The caps have mechanical damage to the thread m10x1.25, the color is peeled off in certain places, and the inside does have some nicks and gouges which could have come from a too deep insertion position with the screwdriver.The review of the device history records showed no deviation to the specifications.No indication for material or design related issue was found.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 7.0MM TI MATRIX MONOAXIAL SCREW 55MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4492535
• MDR Text Key: 5327534
• Report Number: 1000562954-2015-10043
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.633.755
• Device Lot Number: 8241706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 85