MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS COLLECT.NO.QAS SPINE SPECIALITIES; SPINAL SPECIALITIES AND OTHERS

Model Number AE-QAS-SP45

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa.Activ-l placed in (b)(6) 2016 progressively migrated anteriorly.Postop device failure.Surgeon opted for posterior fixation and observation.Implant originally placed (b)(6) 2016 lumbar tdr (total disc replacement).Intervention: posterior pedicle screw fixation (b)(6) 2017.Additional intervention needed a posterior pedicle screw fixation.

Manufacturer Narrative

Investigation: no product at hand.Batch history review: the manufacturing documents have been checked and found to be according to specification valid at the time of production.Conclusion and root cause: the root cause of the problem is most probably usage or patient related.Rational: because there is not x-rays or products available for analysis, a definitive root cause can not be determined.According to the case description, a material defect or manufacturing error can be excluded.No capa is necessary.

Manufacturer Narrative

Additional information: components in use listed as concomitant devices are: sw892k / activ l sup.Plate size xl 11°/spikes - lot number 52149379.Sw965 / activ l pe-inlay 8.5mm - lot number 52161114.Sw890k / activ l inf.Plate size xl 0°/spikes - lot number 52159727.

Event Description

Components in use listed as concomitant devices are: sw892k / activ l sup.Plate size xl 11°/spikes - lot number 52149379.Sw965 / activ l pe-inlay 8.5mm - lot number 52161114.Sw890k / activ l inf.Plate size xl 0°/spikes - lot number 52159727.

• Brand Name: COLLECT.NO.QAS SPINE SPECIALITIES
• Type of Device: SPINAL SPECIALITIES AND OTHERS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 6865556
• MDR Text Key: 86634107
• Report Number: 9610612-2017-00464
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-SP45
• Device Catalogue Number: AE-QAS-SP45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/13/2017
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention