MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ACTIV C IMPLANT FLAT SIZE XXL 5MM; ACTIV C IMPLANTS

Model Number SW299K

Device Problems Product Quality Problem (1506); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).The first prosthesis was not properly stored in the packaging.Both parts cranial/caudal were not in the designated receptacle (inner packaging).When implanted into the intervertebral space, the implant was too loose on the insert instrument and dislodged/displaced when inserted into the intervertebral space and was also removed.The second implant was then opened and it was immediately seen that in the inner packaging both parts were not in the designated receptacle.Thereafter, the next size was taken, but the bone or the intervertebral space had to be further milled to fit this size.Surgery delay approx.40 min.Components in use listed as concomitant devices are: sw299k / activ c implant flat size xxl 5mm, fw863r / activ c spacer h5mm.

Manufacturer Narrative

(b)(4).Exemption number: e2014018.Manufacturing site evaluation: it was initially reported this complaint should not have been reported, this device was not marketed in united states.No additional follow up will be filed related to this issue.

• Brand Name: ACTIV C IMPLANT FLAT SIZE XXL 5MM
• Type of Device: ACTIV C IMPLANTS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7232635
• MDR Text Key: 98985129
• Report Number: 9610612-2018-00029
• Device Sequence Number: 1
• Product Code: LYQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: SW299K
• Device Catalogue Number: SW299K
• Device Lot Number: 51951682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/15/2018
• Device Age: 4 YR
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2013
• 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): Other