• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 04.632.745
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 12/23/2018
Event Type  Injury  
Manufacturer Narrative
Additional product codes; mnh, mni, kwq, kwp. (b)(4). The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during an unknown procedure, the threads of the four (4) pedicle matrix screws, and (1) locking cap were peeled or torn, one (1) unknown rod was damaged, and it could not be removed after locking. The surgeon had to remove the devices with an external force. The surgeon changed another same device to complete the procedure. The procedure time prolonged to 3 hours. Patient outcome is unknown. Concomitant device reported: unknown rod (part #: unknown, lot #: unknown, quantity: 1). This complaint involves four (4) devices. This report is for (1) 7. 0mm ti matrix polyaxial screw 45mm thread length. This report is 1 of 4 for (b)(4).
 
Manufacturer Narrative
Visual inspection: visual inspection of the device shows damage to the polyaxial head and it can¿t rotate freely because its locked between the locking cap and rod. The balance of the device is in worn/fair condition. The received condition does agree with complaint description and is confirmed. Dimensional inspection: a dimensional inspection could not be performed due to post manufacturing damage and jammed condition of the implant. Document/specification review a device history review, was performed for the returned instrument¿s lot number, and no ncrs, no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition. Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown. During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot part number 04. 632. 745 lot number: h184114 date of manufacture: 09-08-2016 place of manufacture: (b)(4). Part expiration date: n/a (nonsterile) the device history record(s) showed that there were no nonconformances or issues during the manufacture of the product that would contribute to this complaint condition. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key8254076
MDR Text Key133318544
Report Number8030965-2019-59943
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819347847
UDI-Public(01)07611819347847
Combination Product (y/n)N
PMA/PMN Number
K100952
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.632.745
Device Lot NumberH184114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 01/16/2019 Patient Sequence Number: 1
-
-