MAUDE Adverse Event Report: SYNTHES BETTLACH VERTEBRAL SPACER-PR 8MMX22MM 7MM HEIGHT¿STERILE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 889.844S

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.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 screwdriver broke during fixation of a plivios vertebral spacer.The spacer also broke during the event.All broken off pieces were removed from the patient.There was no adverse to the patient and the surgery was not delayed due to the reported event.The patient's postoperative status was reported as ¿ok.¿ this report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: the product was not returned in the original packaging.The laser etching was readable.The product is broken in places with scratches and small fragments missing.A device history record (dhr) review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.The part dimensions could not be verified due to the damage of the part.The raw material used for the article is peek.No manufacturing error could be detected and the part successfully passed a quality inspection.Based on this the complaint is rated as confirmed and not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and/or confirmed.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: VERTEBRAL SPACER-PR 8MMX22MM 7MM HEIGHT¿STERILE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5398368
• MDR Text Key: 37105165
• Report Number: 9612488-2016-10063
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 889.844S
• Device Lot Number: 8405922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1