MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH LOCKSCR SYNAPSE TAN; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.508S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Patient information not available for reporting.Original implant date is unknown, device is still implanted.Device is not expected to return; it is currently still implanted.Contact phone number is not available.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the set screw had been dislodged postoperatively on an unknown date.X-rays taken on an unknown date determined that the screw had migrated.Revision surgery will be required but is not currently scheduled.It is unknown when the original surgery took place.(b)(4).

Manufacturer Narrative

Product code, common device name.Additional product codes: kwp, mnh, mni.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

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.

Event Description

It has been reported that re-operation is not planned for the time being.

• Brand Name: LOCKSCR SYNAPSE TAN
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7155013
• MDR Text Key: 96057774
• Report Number: 8030965-2017-51017
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819328747
• UDI-Public: (01)07611819328747(17)UNKNOWN(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention